December 30, 2010 Published in AGE OF AUTISM
SANEVAX Questions the FDA Approval of Merck's Gardasil for anal cancer. Dr. Julie Gerberding, head of the vaccine division for Merck, was the head of the CDC under President Bush, and was responsible for the pediatric vaccine schedule, which included adding Dr. Paul Offit's Merck vaccine RotaTeq during her watch. From SANEVAX, a watchdog group concerned with adverse reactions, including death, from the genital wart vaccine called Gardasil (and it's competitor from GlaxoSmithKline Cevarix.)
...According to the National Cancer Institute, an estimated 5,260 people will be diagnosed with anal cancer in 2010 (United States). 720 fatalities due to anal cancer are anticipated. The average age at diagnosis is 60. The data presented in a 1996 study indicates you are over 10 times more likely to die from an overdose of over-the-counter pain medications, such as aspirin, than you are to die of anal cancer. Merck made no mention of these facts anywhere in the documentation they presented to the FDA.
SaneVax wants to know, “In what universe does this make a convincing argument for vaccinating people ages 9 to 26?”
Read the full story at http://sanevax.org/blog/?p=1594.
Thursday, December 30, 2010
Wednesday, December 29, 2010
Gardasil: Merck presents more flawed data - FDA grants extended use
The FDA continues to spark controversy over Merck's Gardasil vaccine, as they ignore scientific principles to grant approval for extended use as a preventative for anal cancer and anal intraepithelial neoplasm. The SaneVax Team wants to know why.
Wednesday, December 22, 2010, Merck announced the FDA had granted permission for Gardasil to be used in the prevention of anal cancer in the male and female population, ages 9 through 26.
The SaneVax team finds this situation appalling, to say the least. After having studied the information Merck presented to the FDA Vaccines and Related Biologics Committee (VRBPAC) to secure this extended use, we cannot sit idly by and let medical consumers around the world accept these ‘facts’ at face value.
First, let it be said that any Advisory Committee Open Meetings to review applications for extended use are supposed to be public. The FDA has yet to publish the minutes from the meeting where they agreed to expand Gardasil’s use to include AIN and anal cancer.
Second, medical consumers need to know the real threat anal cancer presents. According to the National Cancer Institute, an estimated 5,260 people will be diagnosed with anal cancer in 2010 (United States). 720 fatalities due to anal cancer are anticipated. The average age at diagnosis is 60. The data presented in a 1996 study indicates you are over 10 times more likely to die from an overdose of over-the-counter pain medications, such as aspirin, than you are to die of anal cancer. Merck made no mention of these facts anywhere in the documentation they presented to the FDA.
SaneVax wants to know, “In what universe does this make a convincing argument for vaccinating people ages 9 to 26?”
In addition, Merck once again blatantly chose a double standard to set the endpoints for efficacy analysis to suit different purposes within the same document. On one hand, they quoted the authoritative National Cancer Institute (NCI) opinion that high-grade AIN 2/3 is a premalignant lesion in order to justify using reversible and poorly defined precancerous histological changes as the endpoint for evaluating Gardasil’s potential to prevent anal cancer.
On the other hand, when it came to ‘judging’ the real efficacy of Gardasil against premalignant lesions, they suddenly switched to using AIN of any grade, not necessarily high grade 2/3, as the determining factor. This is a gross deception because, as Merck should have known, AIN grade 1, and grade 2, lesions are frequently self-reversing and do not lead to cancer at all.
Furthermore, Merck stated HPV infection is the key in pathogenesis of anal cancer. In their selection of MSM (males who have sex with males) study subjects, Merck emphasized that key exclusion criteria included a history of HPV-related disease or infection. However, potential subjects were only examined for ‘visible signs’ of HPV infection; not screened via PCR, or tested for seropositivity prior to enrollment.
On the other hand, under Disease Endpoint Adjudication, it was required that at least one of HPV types 6, 11, 16 or 18 detected be confirmed by Thinsection PCR. Since no PCR testing was performed at the time of enrollment, a high percentage of study subjects already infected with HPV, but without ‘visible signs,’ might have been assigned to the placebo group, thus giving the vaccine group an artificially high appearance of efficacy. Since there was no PCR-based common denominator established at the outset of the clinical trial, efficacy results based on PCR endpoint analysis should not be accepted as valid.
For confirmation of type-specific HPV infections during the trials, Merck did not use an FDA-approved genotyping method, or, the reliable HPV DNA short target sequences genotyping recommended by the NCI. Because of this choice, no one knows how many subjects began the trials with prior exposure to vaccine-relevant HPV; nor does anyone know for sure how many subjects were infected by any vaccine-relevant HPV at the end of the trials.
One additional problem is HPV types 6 and 11 are classified as low risk, meaning they are not normally associated with any type of cancer. Even so, Merck included 19 cases of AIN related to these two low-risk HPV genotypes to demonstrate the ‘efficacy’ of Gardasil against anal cancer.
SaneVax believes perhaps it is time the FDA stop claiming they are a “science-based, science-driven regulatory agency responsible for the safety, efficacy and security of drugs and medical devices.”
When it comes to the safety, efficacy and security of FDA approved vaccines medical consumers are apparently on their own.
Sources:
http://sanevax.org/pdf/VRBPAC-gardasil-2010-anal-cancer.pdf
http://www.cancer.gov/cancertopics/types/anal
http://drugwarfacts.org/cms/?q=node/30
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm181509.htm
For more information, go to http://sanevax.org/
Wednesday, December 22, 2010, Merck announced the FDA had granted permission for Gardasil to be used in the prevention of anal cancer in the male and female population, ages 9 through 26.
The SaneVax team finds this situation appalling, to say the least. After having studied the information Merck presented to the FDA Vaccines and Related Biologics Committee (VRBPAC) to secure this extended use, we cannot sit idly by and let medical consumers around the world accept these ‘facts’ at face value.
First, let it be said that any Advisory Committee Open Meetings to review applications for extended use are supposed to be public. The FDA has yet to publish the minutes from the meeting where they agreed to expand Gardasil’s use to include AIN and anal cancer.
Second, medical consumers need to know the real threat anal cancer presents. According to the National Cancer Institute, an estimated 5,260 people will be diagnosed with anal cancer in 2010 (United States). 720 fatalities due to anal cancer are anticipated. The average age at diagnosis is 60. The data presented in a 1996 study indicates you are over 10 times more likely to die from an overdose of over-the-counter pain medications, such as aspirin, than you are to die of anal cancer. Merck made no mention of these facts anywhere in the documentation they presented to the FDA.
SaneVax wants to know, “In what universe does this make a convincing argument for vaccinating people ages 9 to 26?”
In addition, Merck once again blatantly chose a double standard to set the endpoints for efficacy analysis to suit different purposes within the same document. On one hand, they quoted the authoritative National Cancer Institute (NCI) opinion that high-grade AIN 2/3 is a premalignant lesion in order to justify using reversible and poorly defined precancerous histological changes as the endpoint for evaluating Gardasil’s potential to prevent anal cancer.
On the other hand, when it came to ‘judging’ the real efficacy of Gardasil against premalignant lesions, they suddenly switched to using AIN of any grade, not necessarily high grade 2/3, as the determining factor. This is a gross deception because, as Merck should have known, AIN grade 1, and grade 2, lesions are frequently self-reversing and do not lead to cancer at all.
Furthermore, Merck stated HPV infection is the key in pathogenesis of anal cancer. In their selection of MSM (males who have sex with males) study subjects, Merck emphasized that key exclusion criteria included a history of HPV-related disease or infection. However, potential subjects were only examined for ‘visible signs’ of HPV infection; not screened via PCR, or tested for seropositivity prior to enrollment.
On the other hand, under Disease Endpoint Adjudication, it was required that at least one of HPV types 6, 11, 16 or 18 detected be confirmed by Thinsection PCR. Since no PCR testing was performed at the time of enrollment, a high percentage of study subjects already infected with HPV, but without ‘visible signs,’ might have been assigned to the placebo group, thus giving the vaccine group an artificially high appearance of efficacy. Since there was no PCR-based common denominator established at the outset of the clinical trial, efficacy results based on PCR endpoint analysis should not be accepted as valid.
For confirmation of type-specific HPV infections during the trials, Merck did not use an FDA-approved genotyping method, or, the reliable HPV DNA short target sequences genotyping recommended by the NCI. Because of this choice, no one knows how many subjects began the trials with prior exposure to vaccine-relevant HPV; nor does anyone know for sure how many subjects were infected by any vaccine-relevant HPV at the end of the trials.
One additional problem is HPV types 6 and 11 are classified as low risk, meaning they are not normally associated with any type of cancer. Even so, Merck included 19 cases of AIN related to these two low-risk HPV genotypes to demonstrate the ‘efficacy’ of Gardasil against anal cancer.
SaneVax believes perhaps it is time the FDA stop claiming they are a “science-based, science-driven regulatory agency responsible for the safety, efficacy and security of drugs and medical devices.”
When it comes to the safety, efficacy and security of FDA approved vaccines medical consumers are apparently on their own.
Sources:
http://sanevax.org/pdf/VRBPAC-gardasil-2010-anal-cancer.pdf
http://www.cancer.gov/cancertopics/types/anal
http://drugwarfacts.org/cms/?q=node/30
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm181509.htm
For more information, go to http://sanevax.org/
Monday, December 27, 2010
S.A.N.E Vax Objects to FDA Ruling Gardasil Use for Anal Cancer for 9 to 26 year olds
Increasing Number of Consumers are Concerned over HPV Vaccine Safety. When will the FDA and the CDC take the initiative to investigate the side effects of the HPV Vaccines?
The FDA’s December 22, 2010 ruling to expand the use of Gardasil for anal cancer prevention is unacceptable, according to Norma Erickson, President of S.A.N.E Vax. Last Wednesday, the U.S. Food and Drug Administration approved Gardasil for the prevention of anal cancer and associated pre-cancer lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Immediately, the news flooded the media – with many postings on HIV/AIDS sites.
However, medical consumers are unaware the 2010 Gardasil® Patient Product Information (PPI) states if a woman has “…immune problems, like HIV infection, cancer, or takes medicines that affect the immune system” they must be reported to the health care provider. This should be of grave concern to HIV/AID patients and their physicians who may consider the vaccine to “prevent” anal cancer.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females in the same age group.
This same group of women has reported over 20,915 adverse reactions – mostly from Gardasil to VAERS – the Vaccine Adverse Event Reporting System. In addition, 89 deaths and 382 abnormal pap tests post vaccination have been reported with an estimated 1 to 10% of the population filing, according to the National Vaccine Information Center. The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered, and therefore CDC statistics on reported injuries are not portraying the truth.
Data on adverse reactions from males ages 9 to 26 are just starting to be reported to VAERS. Hundreds of social media sited, journalists, researchers and educators have joined forces to publicly decry the faulty science, data, research and fast-tracking of this vaccine through the FDA.
Of course, Merck & Co. denies a causal relationship between the adverse reactions and deaths to their award-winning vaccine. However, on December 20, the QMI News Agency in Canada reported a Quebec coroner can't explain why a 14-year-old girl died after receiving a dose of the Gardasil vaccine. Even though coroner Michel Ferland's report concludes the adolescent girl died from drowning, and while there is no evidence the shot killed the teenager, he is refusing to rule out a link between Gardasil and her death.
On December 13, Michael Smith, North American Correspondent, MedPage Today wrote an article titled: Many Fail to Finish HPV Series as Recommended stating that “…Many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion…” According to Dr. Lea Widdice, Cincinnati Children's Hospital Medical Center; in a single-institution retrospective analysis, only 14% of girls and young women completed all three doses within seven months of the first, and only 28% did so within 12 months.
Although statistical data was cited for non-compliance, SANE VAX wants to know if the girls were surveyed for their reasons in not completing the vaccine series. Until the true reasons are known, consumers must remain wary about the potential health dangers from the administration of Gardasil and Cervarix.
According to the FDA there are limitations on the use and effectiveness of Gardasil:
• GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
• GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
• GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.
• GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.
• Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.
• GARDASIL does not protect against genital diseases not caused by HPV.
• Vaccination with GARDASIL may not result in protection in all vaccine recipients.
According to the recently revised copy of “Cervical Cancer Prevention, Health Professional Version,” published by the National Cancer Institute (NCI): “The finding of HPV viral DNA integrated in most cellular genomes of cervical carcinomas supports epidemiologic data linking this agent to cervical cancer however, direct causation has not been demonstrated.”
On October 19, 2010 S.A.N.E. Vax submitted a formal letter to Jack Stapleton, M.D., Chair Vaccines and Related Biological Products Advisory Committee regarding Valid endpoint and reliable HPV genotyping for expanded use proposal of Gardasil® vaccine stating… “In the interest of promoting and protecting the public health, S.A.N.E. Vax, Inc. respectfully requests that expanded use for Gardasil® as an anal cancer preventive vaccine be delayed, until such time as the efficacy of the vaccine is properly evaluated using the true endpoint for anal cancer prevention, and a reliable HPV genotyping method for detection of type-specific HPV infections.”
The Gardasil vaccine campaign on unsuspecting and ill-informed medical consumers must be halted until an independent study demonstrates the safety and efficacy of the vaccine. As it stands, this is a classic case of pharma/government vs. medical consumers with monumental social/political implications. The HPV vaccine travesty will go down in history as an example of unethical experimental medical procedures harming the health and well being of the very people the vaccines were supposedly designed to protect.
For more information, visit our site at http://sanevax.org/.
The FDA’s December 22, 2010 ruling to expand the use of Gardasil for anal cancer prevention is unacceptable, according to Norma Erickson, President of S.A.N.E Vax. Last Wednesday, the U.S. Food and Drug Administration approved Gardasil for the prevention of anal cancer and associated pre-cancer lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Immediately, the news flooded the media – with many postings on HIV/AIDS sites.
However, medical consumers are unaware the 2010 Gardasil® Patient Product Information (PPI) states if a woman has “…immune problems, like HIV infection, cancer, or takes medicines that affect the immune system” they must be reported to the health care provider. This should be of grave concern to HIV/AID patients and their physicians who may consider the vaccine to “prevent” anal cancer.
Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females in the same age group.
This same group of women has reported over 20,915 adverse reactions – mostly from Gardasil to VAERS – the Vaccine Adverse Event Reporting System. In addition, 89 deaths and 382 abnormal pap tests post vaccination have been reported with an estimated 1 to 10% of the population filing, according to the National Vaccine Information Center. The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered, and therefore CDC statistics on reported injuries are not portraying the truth.
Data on adverse reactions from males ages 9 to 26 are just starting to be reported to VAERS. Hundreds of social media sited, journalists, researchers and educators have joined forces to publicly decry the faulty science, data, research and fast-tracking of this vaccine through the FDA.
Of course, Merck & Co. denies a causal relationship between the adverse reactions and deaths to their award-winning vaccine. However, on December 20, the QMI News Agency in Canada reported a Quebec coroner can't explain why a 14-year-old girl died after receiving a dose of the Gardasil vaccine. Even though coroner Michel Ferland's report concludes the adolescent girl died from drowning, and while there is no evidence the shot killed the teenager, he is refusing to rule out a link between Gardasil and her death.
On December 13, Michael Smith, North American Correspondent, MedPage Today wrote an article titled: Many Fail to Finish HPV Series as Recommended stating that “…Many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion…” According to Dr. Lea Widdice, Cincinnati Children's Hospital Medical Center; in a single-institution retrospective analysis, only 14% of girls and young women completed all three doses within seven months of the first, and only 28% did so within 12 months.
Although statistical data was cited for non-compliance, SANE VAX wants to know if the girls were surveyed for their reasons in not completing the vaccine series. Until the true reasons are known, consumers must remain wary about the potential health dangers from the administration of Gardasil and Cervarix.
According to the FDA there are limitations on the use and effectiveness of Gardasil:
• GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
• GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
• GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.
• GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.
• Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.
• GARDASIL does not protect against genital diseases not caused by HPV.
• Vaccination with GARDASIL may not result in protection in all vaccine recipients.
According to the recently revised copy of “Cervical Cancer Prevention, Health Professional Version,” published by the National Cancer Institute (NCI): “The finding of HPV viral DNA integrated in most cellular genomes of cervical carcinomas supports epidemiologic data linking this agent to cervical cancer however, direct causation has not been demonstrated.”
On October 19, 2010 S.A.N.E. Vax submitted a formal letter to Jack Stapleton, M.D., Chair Vaccines and Related Biological Products Advisory Committee regarding Valid endpoint and reliable HPV genotyping for expanded use proposal of Gardasil® vaccine stating… “In the interest of promoting and protecting the public health, S.A.N.E. Vax, Inc. respectfully requests that expanded use for Gardasil® as an anal cancer preventive vaccine be delayed, until such time as the efficacy of the vaccine is properly evaluated using the true endpoint for anal cancer prevention, and a reliable HPV genotyping method for detection of type-specific HPV infections.”
The Gardasil vaccine campaign on unsuspecting and ill-informed medical consumers must be halted until an independent study demonstrates the safety and efficacy of the vaccine. As it stands, this is a classic case of pharma/government vs. medical consumers with monumental social/political implications. The HPV vaccine travesty will go down in history as an example of unethical experimental medical procedures harming the health and well being of the very people the vaccines were supposedly designed to protect.
For more information, visit our site at http://sanevax.org/.
Monday, December 13, 2010
HPV Vaccine (Gardasil and Cervarix) VAERS Reports - Injury Statistics Increasing at Rapid Rate
The injury and death related to the HPV Vaccines Gardasil and Cervarix continue to rise. How many will it take before the FDA takes action?
Dec 13, 2010 – One week ago SANE Vax researcher, Janny Stokvis of the Netherlands reported the latest VAERS data on deaths and injury from the HPV vaccines.
Those numbers stood at:
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)
As of December 13, 2010 new reports state:
20,915 adverse injuries - an increase of 340 adverse events in one week.
370 reports of abnormal pap smears post vaccination (18 new cases submitted in a week, three are related to Cervarix)
Reported deaths remain the same - 89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)
On December 13, 2010 Medpage Today released this article:
Many Fail to Finish HPV Vaccine Series as Recommended (http://www.medpagetoday.com/Pediatrics/Vaccines/23873)
Researchers reported that many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion.
SANE Vax believes that it is high time to take into consideration that many girls are not completing the series because of adverse reactions to the HPV vaccines.
For more information, visit http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Dec 13, 2010 – One week ago SANE Vax researcher, Janny Stokvis of the Netherlands reported the latest VAERS data on deaths and injury from the HPV vaccines.
Those numbers stood at:
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)
As of December 13, 2010 new reports state:
20,915 adverse injuries - an increase of 340 adverse events in one week.
370 reports of abnormal pap smears post vaccination (18 new cases submitted in a week, three are related to Cervarix)
Reported deaths remain the same - 89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) now missing from VAERS)
On December 13, 2010 Medpage Today released this article:
Many Fail to Finish HPV Vaccine Series as Recommended (http://www.medpagetoday.com/Pediatrics/Vaccines/23873)
Researchers reported that many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion.
SANE Vax believes that it is high time to take into consideration that many girls are not completing the series because of adverse reactions to the HPV vaccines.
For more information, visit http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Tasmanian girls urged to get immunized against cervical cancer: Where is the common sense?
What criteria do governments use to decide whether the benefits of a vaccine outweigh the risks? On what basis do they judge whether a vaccine should be 'recommended' or 'mandated?" Does common sense enter the equation?
Dec 13, 2010 – Friday, 10 December 2010, Dr. Roscoe Taylor, Director of Public Health, issued a press release urging “all teenage girls in Tasmania to be vaccinated against the Human Papilloma Viirus (HPV) which causes cervical cancer.”
The SaneVax Team believes this strategy makes no sense at all.
Let’s ignore the fact no one will know if HPV vaccines actually prevent cervical cancer for at least ten years.
Let’s ignore the fact no one knows when booster shots will be required.
Let’s ignore the fact cervical cancer is not a contagious disease.
Let’s ignore the fact almost 90%, of HPV infections clear on their own with no medical intervention and no symptoms.
Let’s ignore the fact good gynecological care has substantially reduced the risk of cervical cancer in developed countries, and continues to do so.
Let’s even ignore the fact HPV vaccination does not eliminate the need for good gynecological care.
Let’s ignore the fact that every vaccine carries some sort of risk to future health and possibly life.
According to the Australian Bureau of Statistics, there are approximately 503,300 people residing in Tasmania. 6.5% of these are teenage girls, or approximately 32,700. The most recent Tasmanian Cancer Registry data show that there were only 21 cases of cervical cancers diagnosed and seven deaths in 2007.
Using a conservative estimate of $300 per series of HPV vaccinations, it will cost $9.8 million to inoculate 32,700 girls in an attempt to save 7 lives that could have been saved with regular visits to the gynecologist and proper follow-up when abnormal cells were detected.
The SaneVax Team wants to know how the Australian government can possibly justify the expenditure of such a vast amount of public money gambling on the fact HPV vaccinations will be effective ten or fifteen years down the road. Research states it will be 20 years before it is known whether the HPV vaccines will have impacted cervical cancer rates. Is it worth gamble when innocent lives may be affected from adverse reactions and/or death?
Sources:
* View Dr. Taylor’s press release here: http://www.media.tas.gov.au/release.php?id=31195
* View info from Australian Bureau of Statistics here:
http://www.abs.gov.au/ausstats/abs@.nsf/Products/3235.0~ ...
* View Diane Harper’s comments here: http://www.naturalnews.com/027196_cancer_cervical_cancer ...
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
For more information, see http://sanevax.org
Dec 13, 2010 – Friday, 10 December 2010, Dr. Roscoe Taylor, Director of Public Health, issued a press release urging “all teenage girls in Tasmania to be vaccinated against the Human Papilloma Viirus (HPV) which causes cervical cancer.”
The SaneVax Team believes this strategy makes no sense at all.
Let’s ignore the fact no one will know if HPV vaccines actually prevent cervical cancer for at least ten years.
Let’s ignore the fact no one knows when booster shots will be required.
Let’s ignore the fact cervical cancer is not a contagious disease.
Let’s ignore the fact almost 90%, of HPV infections clear on their own with no medical intervention and no symptoms.
Let’s ignore the fact good gynecological care has substantially reduced the risk of cervical cancer in developed countries, and continues to do so.
Let’s even ignore the fact HPV vaccination does not eliminate the need for good gynecological care.
Let’s ignore the fact that every vaccine carries some sort of risk to future health and possibly life.
According to the Australian Bureau of Statistics, there are approximately 503,300 people residing in Tasmania. 6.5% of these are teenage girls, or approximately 32,700. The most recent Tasmanian Cancer Registry data show that there were only 21 cases of cervical cancers diagnosed and seven deaths in 2007.
Using a conservative estimate of $300 per series of HPV vaccinations, it will cost $9.8 million to inoculate 32,700 girls in an attempt to save 7 lives that could have been saved with regular visits to the gynecologist and proper follow-up when abnormal cells were detected.
The SaneVax Team wants to know how the Australian government can possibly justify the expenditure of such a vast amount of public money gambling on the fact HPV vaccinations will be effective ten or fifteen years down the road. Research states it will be 20 years before it is known whether the HPV vaccines will have impacted cervical cancer rates. Is it worth gamble when innocent lives may be affected from adverse reactions and/or death?
Sources:
* View Dr. Taylor’s press release here: http://www.media.tas.gov.au/release.php?id=31195
* View info from Australian Bureau of Statistics here:
http://www.abs.gov.au/ausstats/abs@.nsf/Products/3235.0~ ...
* View Diane Harper’s comments here: http://www.naturalnews.com/027196_cancer_cervical_cancer ...
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
For more information, see http://sanevax.org
Thursday, December 9, 2010
Gardasil Approval: FDA Apparently Does Not Follow Its Own Rules
Did the FDA grant approval for Gardasil the HPV Vaccine even though it didn't meet their criteria?
Dec 10, 2010 – According to FDA rules, in order to obtain ‘fast-track’ approval a new drug or medical treatment, two criteria must be satisfied. The drug/treatment must be for a serious disease and it must fill an unmet medical need. According to the FDA, filling an ‘unmet medical need’ is defined as, “providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.”
There is no doubt cervical cancer is a serious disease. However, one has to question how Gardasil met the second criteria of filling an ‘unmet’ medical need. Due to regular cervical cancer screening and appropriate medical follow-up when abnormal cervical cells are detected, cervical cancer rates in the United States have dropped over 74% and continue to decline. This is the case in most developed countries around the world. So, where is the ‘unmet medical need?’
Another problem arises when HPV is purported to be a cause of cervical cancer. Several high-risk genotypes of human papillomavirus (HPV) have been associated with cervical cancer, but not established as a cause of cancer. Persistent HPV infections occurring from the same genotype, increase the risk of cancer. No one has determined whether or not persistent infections actually cause cancer without other risk factors being present.
The truth is 90% of all HPV infections clear on their own without medical intervention. Of the 10% left, only 5% of these will ever develop into cancerous cells. Cervical cancer takes between 5 and 15 years to develop. 95% of cervical cancer is treatable and curable. Almost all fatalities from cervical cancer can be avoided with good gynecological care. Again, where is the ‘unmet medical need?’
In addition to these two criteria, FDA guidelines say, if there are existing therapies for the disease a proposed drug/treatment is intended for a fast-track drug must show some advantage over available treatment(s), such as:
1. Showing superior effectiveness – Gardasil will not be able to show that for at least 10-15 years.
2. Avoiding serious side effects – there are no serious side effects to regular screening and appropriate follow-up.
3. Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome – not applicable to HPV vaccines.
4. Decreasing a clinically significant toxicity of an accepted treatment – again, not applicable to HPV vaccines.
Despite the fact that the only criteria Gardasil could have possibly met was the intent to combat a serious disease, the FDA granted fast-track approval for the product in June of 2006.
Now, American medical consumers have seen the post-HPV vaccination adverse events reports approaching 21,000 and there are 89 families who have ‘one less’ child. Perhaps, the FDA needs to study the rules.
Sources:
View http://www.fda.gov/downloads/Drugs/GuidanceComplianceReg ... for more information on FDA fast-track approval guidelines.
View http://www.infectiousdiseasenews.com/article.aspx?id=37036 for more information on HPV clearing on its own.
View http://womenshealth.about.com/cs/cervicalcancer/a/hpvcer ... for more information on the HPV connection to cervical cancer.
Please visit our site at http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Dec 10, 2010 – According to FDA rules, in order to obtain ‘fast-track’ approval a new drug or medical treatment, two criteria must be satisfied. The drug/treatment must be for a serious disease and it must fill an unmet medical need. According to the FDA, filling an ‘unmet medical need’ is defined as, “providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.”
There is no doubt cervical cancer is a serious disease. However, one has to question how Gardasil met the second criteria of filling an ‘unmet’ medical need. Due to regular cervical cancer screening and appropriate medical follow-up when abnormal cervical cells are detected, cervical cancer rates in the United States have dropped over 74% and continue to decline. This is the case in most developed countries around the world. So, where is the ‘unmet medical need?’
Another problem arises when HPV is purported to be a cause of cervical cancer. Several high-risk genotypes of human papillomavirus (HPV) have been associated with cervical cancer, but not established as a cause of cancer. Persistent HPV infections occurring from the same genotype, increase the risk of cancer. No one has determined whether or not persistent infections actually cause cancer without other risk factors being present.
The truth is 90% of all HPV infections clear on their own without medical intervention. Of the 10% left, only 5% of these will ever develop into cancerous cells. Cervical cancer takes between 5 and 15 years to develop. 95% of cervical cancer is treatable and curable. Almost all fatalities from cervical cancer can be avoided with good gynecological care. Again, where is the ‘unmet medical need?’
In addition to these two criteria, FDA guidelines say, if there are existing therapies for the disease a proposed drug/treatment is intended for a fast-track drug must show some advantage over available treatment(s), such as:
1. Showing superior effectiveness – Gardasil will not be able to show that for at least 10-15 years.
2. Avoiding serious side effects – there are no serious side effects to regular screening and appropriate follow-up.
3. Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome – not applicable to HPV vaccines.
4. Decreasing a clinically significant toxicity of an accepted treatment – again, not applicable to HPV vaccines.
Despite the fact that the only criteria Gardasil could have possibly met was the intent to combat a serious disease, the FDA granted fast-track approval for the product in June of 2006.
Now, American medical consumers have seen the post-HPV vaccination adverse events reports approaching 21,000 and there are 89 families who have ‘one less’ child. Perhaps, the FDA needs to study the rules.
Sources:
View http://www.fda.gov/downloads/Drugs/GuidanceComplianceReg ... for more information on FDA fast-track approval guidelines.
View http://www.infectiousdiseasenews.com/article.aspx?id=37036 for more information on HPV clearing on its own.
View http://womenshealth.about.com/cs/cervicalcancer/a/hpvcer ... for more information on the HPV connection to cervical cancer.
Please visit our site at http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Wednesday, December 8, 2010
Gardasil’s Trail of Deception
Doe's Gardasil’s Trail of Deception Hides the True Scope of Death and Injuries?
While the number of deaths and serious adverse events reported due to Merck's controversial Gardasil vaccine continues to grow alarmingly, the true number of people who have been killed or injured by the deadly vaccine is likely far higher. The truth about Gardasil has been deliberately hidden through a trail of deception, cover-ups, ignorance and under-reporting that dates back to the very inception of the vaccine.
The first key deception occurred during Gardasil trials. Instead of using a saline solution as the placebo, Merck used the vaccine's carrier agent minus only the HPV virus components. In addition to sodium chloride and water normally found in a saline solution placebo, the placebo Merck chose also contained dangerous aluminum along with polysorbate 80 and sodium borate.
Although polysorbate 80 is used as a food additive to increase the water solubility of flavoring oils, injection is quite different. According to the polysorbate 80 Material Safety Data Sheet, it may be carcinogenic as well as mutagenic. When injected into prepubescent rats, polysorbate 80 caused abnormal growth of reproductive organs and made the rats sterile. When used intravenously with vitamins, it has been known to cause anaphylactic shock.
An analysis of the actual trial data for Gardasil reveals that a shocking 73.3 percent of the participants who received Gardasil acquired a new medical condition ranging from flu-like symptoms to paralysis. Almost 60% had systemic reactions. Though the “placebo” recipients had similar results, obviously no mere saline solution would have produced even a fraction of such reactions. The results would likely have been even higher if the study had lasted longer than 15 days.
The lack of dangers in the prescribing information furnished to doctors by Merck and the VAERS requirement that only serious and life-threatening events be reported both likely play big roles in the under-reporting of Gardasil reactions. Doctors are reluctant to report deaths and injuries from anything they administered or performed in the first place, and the lack of information and guidelines have insured that they are far less likely to report anywhere near all the adverse reactions from Gardasil.
Other factors which help skew the picture of Gardasil dangers include:
*The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered.
*Gardasil is given in a series of three injections. Thus the number of adverse reactions per number of patients is triple the adverse events per injection.
*Many parents are not aware of the definition of adverse event or that they can file their own VAERS report.
Disturbingly, already reported deaths and reactions may be being hidden or altered to be attributed to other causes. When SANEVAX looked at the latest reported VAERS totals, they discovered that five previous death cases are now inexplicably missing.
Another Gardasil danger which has also been largely hidden and ignored is the danger presented to young women who have already been infected with HPV. Despite the fact that girls (and boys) can be exposed to HPV viruses from birth onwards, there is no screening required and not even a recommendation for screening before a young woman reaches the age of 21.
In a paper Merck submitted to the FDA on young women who tested positive for the HPV strains 16 or 18, the facts are alarming. Protection against the HPV virus for young infected women was much worse than if they had not been vaccinated at all. According to the paper, infected women had who were given Gardasil had a 44.6% increased risk of abnormal cervical cell development than did non vaccinated women.
The true magnitude of Gardasil’s harm and dangers could be horrendous. Reports for other vaccines deaths and adverse reactions are estimated to represent no more than 10% of the actual totals. With Gardasil, estimates range as low as only 1%.
If 10% are reporting, there could be as many as 890 deaths and 205,000 adverse events. If only 1% are actually reported, there could be 8,900 deaths and 2,050,000 adverse events.
Behind Gardasil's trail of deception is a very large and mostly hidden trail of tears. Parents and the general public richly deserve to be told the full truth to keep that trail from turning into a raging flood of sorrow and suffering.
Please visit our site at http://sanevax.org/ .
Tony Isaacs, Contributing Author, SaneVax Inc.
Tony Isaacs, is a natural health author, advocate and researcher who hosts The Best Years in Life website http://www.tbyil.com/ for baby boomers and others wishing to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally. Mr. Isaacs is the author of books and articles about natural health, longevity and beating cancer including "Cancer's Natural Enemy" and is working on a major book project due to be published in 2011.
While the number of deaths and serious adverse events reported due to Merck's controversial Gardasil vaccine continues to grow alarmingly, the true number of people who have been killed or injured by the deadly vaccine is likely far higher. The truth about Gardasil has been deliberately hidden through a trail of deception, cover-ups, ignorance and under-reporting that dates back to the very inception of the vaccine.
The first key deception occurred during Gardasil trials. Instead of using a saline solution as the placebo, Merck used the vaccine's carrier agent minus only the HPV virus components. In addition to sodium chloride and water normally found in a saline solution placebo, the placebo Merck chose also contained dangerous aluminum along with polysorbate 80 and sodium borate.
Although polysorbate 80 is used as a food additive to increase the water solubility of flavoring oils, injection is quite different. According to the polysorbate 80 Material Safety Data Sheet, it may be carcinogenic as well as mutagenic. When injected into prepubescent rats, polysorbate 80 caused abnormal growth of reproductive organs and made the rats sterile. When used intravenously with vitamins, it has been known to cause anaphylactic shock.
An analysis of the actual trial data for Gardasil reveals that a shocking 73.3 percent of the participants who received Gardasil acquired a new medical condition ranging from flu-like symptoms to paralysis. Almost 60% had systemic reactions. Though the “placebo” recipients had similar results, obviously no mere saline solution would have produced even a fraction of such reactions. The results would likely have been even higher if the study had lasted longer than 15 days.
The lack of dangers in the prescribing information furnished to doctors by Merck and the VAERS requirement that only serious and life-threatening events be reported both likely play big roles in the under-reporting of Gardasil reactions. Doctors are reluctant to report deaths and injuries from anything they administered or performed in the first place, and the lack of information and guidelines have insured that they are far less likely to report anywhere near all the adverse reactions from Gardasil.
Other factors which help skew the picture of Gardasil dangers include:
*The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered.
*Gardasil is given in a series of three injections. Thus the number of adverse reactions per number of patients is triple the adverse events per injection.
*Many parents are not aware of the definition of adverse event or that they can file their own VAERS report.
Disturbingly, already reported deaths and reactions may be being hidden or altered to be attributed to other causes. When SANEVAX looked at the latest reported VAERS totals, they discovered that five previous death cases are now inexplicably missing.
Another Gardasil danger which has also been largely hidden and ignored is the danger presented to young women who have already been infected with HPV. Despite the fact that girls (and boys) can be exposed to HPV viruses from birth onwards, there is no screening required and not even a recommendation for screening before a young woman reaches the age of 21.
In a paper Merck submitted to the FDA on young women who tested positive for the HPV strains 16 or 18, the facts are alarming. Protection against the HPV virus for young infected women was much worse than if they had not been vaccinated at all. According to the paper, infected women had who were given Gardasil had a 44.6% increased risk of abnormal cervical cell development than did non vaccinated women.
The true magnitude of Gardasil’s harm and dangers could be horrendous. Reports for other vaccines deaths and adverse reactions are estimated to represent no more than 10% of the actual totals. With Gardasil, estimates range as low as only 1%.
If 10% are reporting, there could be as many as 890 deaths and 205,000 adverse events. If only 1% are actually reported, there could be 8,900 deaths and 2,050,000 adverse events.
Behind Gardasil's trail of deception is a very large and mostly hidden trail of tears. Parents and the general public richly deserve to be told the full truth to keep that trail from turning into a raging flood of sorrow and suffering.
Please visit our site at http://sanevax.org/ .
Tony Isaacs, Contributing Author, SaneVax Inc.
Tony Isaacs, is a natural health author, advocate and researcher who hosts The Best Years in Life website http://www.tbyil.com/ for baby boomers and others wishing to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally. Mr. Isaacs is the author of books and articles about natural health, longevity and beating cancer including "Cancer's Natural Enemy" and is working on a major book project due to be published in 2011.
Monday, December 6, 2010
To Expand or Not Expand–That's the Question....Will FDA Approve Merck’s 4th Request to Expand Gardasil?
Research submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010 related to the adverse effects of the HPV Vaccines. Will the FDA respond?
Dec 06, 2010 – Leslie Carol Botha and Cynthia Ann Janak prepared an extensive power point for the FDA on HPV Vaccines Mechanisms of Action in Women – Endocrine Influence, HPV – Pre Testing and Immune System Involvement. The document was submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010.
The information included in the presentation has implications not only for female adolescent health – but for women ages 26 to 45 and older who may be the next age group for HPV vaccination approval.
December 3, 2010 – HPV Vaccine VAERS reports (women ages 9 to 26)
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination.
89 reported deaths – plus 5 reports submitted to the FDA, missing from VAERS, uncovered via the Freedom of Information Act (FOIA) by Judicial Watch
Botha and Janak’s intent is to provide research and data to support the hypothesis that the HPV vaccines may even be more dangerous in an older age group with hope of preventing FDA approval of Merck’s 4th request to expand Gardasil use to older women.
The FDA declined to make a comment about the research presented - nor did they choose to listen to a verbal presentation – nor did they attempt to answer any questions raised by the research presented. Instead Botha and Janak were told via email: The CBER team thanks you for the additional information since the last listening session. At this point, they do not want to have any additional listening sessions, and instead will answer in writing any questions you may have.
Botha and Janak did respond with one additional question:
With the additional information that was presented will the CBER review team be looking at the possibility of suspending the license of the HPV vaccines pending further safety review?
Although acknowledgment was received that the question would be forwarded to CBER, a response has yet to be received.
HPV Vaccine Mechanisms of Action in Women has been converted to a 63 page PDF file (may take some time to download) filled with research and documentation on issues not considered during HPV vaccine clinical trials – nor in any other vaccine or medical trial for that matter.
With all of the studies coming out about the relevance the endocrine system has to women’s health – it is time that the menstrual cycle be given its due as the regulating system in a woman’s body.
Botha and Janak raised the following issues/questions in the HPV Mechanisms of Action Presentation: (Research, data, documentation and corresponding links are documented in the PDF file.)
To read the full story, go to http://sanevax.org/blog/?p=1286.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Dec 06, 2010 – Leslie Carol Botha and Cynthia Ann Janak prepared an extensive power point for the FDA on HPV Vaccines Mechanisms of Action in Women – Endocrine Influence, HPV – Pre Testing and Immune System Involvement. The document was submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010.
The information included in the presentation has implications not only for female adolescent health – but for women ages 26 to 45 and older who may be the next age group for HPV vaccination approval.
December 3, 2010 – HPV Vaccine VAERS reports (women ages 9 to 26)
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination.
89 reported deaths – plus 5 reports submitted to the FDA, missing from VAERS, uncovered via the Freedom of Information Act (FOIA) by Judicial Watch
Botha and Janak’s intent is to provide research and data to support the hypothesis that the HPV vaccines may even be more dangerous in an older age group with hope of preventing FDA approval of Merck’s 4th request to expand Gardasil use to older women.
The FDA declined to make a comment about the research presented - nor did they choose to listen to a verbal presentation – nor did they attempt to answer any questions raised by the research presented. Instead Botha and Janak were told via email: The CBER team thanks you for the additional information since the last listening session. At this point, they do not want to have any additional listening sessions, and instead will answer in writing any questions you may have.
Botha and Janak did respond with one additional question:
With the additional information that was presented will the CBER review team be looking at the possibility of suspending the license of the HPV vaccines pending further safety review?
Although acknowledgment was received that the question would be forwarded to CBER, a response has yet to be received.
HPV Vaccine Mechanisms of Action in Women has been converted to a 63 page PDF file (may take some time to download) filled with research and documentation on issues not considered during HPV vaccine clinical trials – nor in any other vaccine or medical trial for that matter.
With all of the studies coming out about the relevance the endocrine system has to women’s health – it is time that the menstrual cycle be given its due as the regulating system in a woman’s body.
Botha and Janak raised the following issues/questions in the HPV Mechanisms of Action Presentation: (Research, data, documentation and corresponding links are documented in the PDF file.)
To read the full story, go to http://sanevax.org/blog/?p=1286.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Saturday, December 4, 2010
HPV Vaccine (Gardasil and Cervarix) VAERS Reports - Injury and Death Continue to Climb
The injury and death related to the HPV Vaccines Gardasil and Cervarix continue to rise. How many will it take before the FDA takes action?
The VAERS information is now being updated weekly for the HPV Vaccines. As of November 3, 2010 the reports are as follows:
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) are now missing from VAERS)
Case numbers:
# 300741
# 314524
# 321405
# 325151
# 381305
The first four reports are on Judicial Watch.
Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009 - http://www.judicialwatch.org/files/documents/2009/vaersdeathsALL_20090616.pdf.
The other report is in here
Vaccine Adverse Effects Report System (VAERS) serious effects report from May, 2009 to September, 2010 - http://www.judicialwatch.org/files/documents/2010/VAERS-052009-to-092010.pdf
Please visit our site at http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
The VAERS information is now being updated weekly for the HPV Vaccines. As of November 3, 2010 the reports are as follows:
20,575 adverse reactions
352 reports of abnormal pap smears post vaccination
89 reported deaths (plus 5 reports submitted to the FDA obtained by Judicial Watch under the Freedom of Information Act (FOIA) are now missing from VAERS)
Case numbers:
# 300741
# 314524
# 321405
# 325151
# 381305
The first four reports are on Judicial Watch.
Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009 - http://www.judicialwatch.org/files/documents/2009/vaersdeathsALL_20090616.pdf.
The other report is in here
Vaccine Adverse Effects Report System (VAERS) serious effects report from May, 2009 to September, 2010 - http://www.judicialwatch.org/files/documents/2010/VAERS-052009-to-092010.pdf
Please visit our site at http://sanevax.org/.
# # #
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
Thursday, December 2, 2010
HPV vaccine - subsequent adverse reaction - life now
Many people who experience adverse events after vaccination do not want their story told. They believe it is their problem and they must deal with the consequences. One has to respect their need for privacy. The food pyramid below was created by one of these people. She has experienced severe consequences following HPV vaccination. She wishes to keep her personal life, but still feels compelled to let people know how life has been changed for her and many others.
Her version of the healthy food pyramid says it all.
Go to http://sanevax.org/news/hpv.shtml to view the pyramid.
Her version of the healthy food pyramid says it all.
Go to http://sanevax.org/news/hpv.shtml to view the pyramid.
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