21,282 Adverse Injuries & 93 Deaths Reported to VAERS
Images Are More Powerful than Numbers
“A mother knows better than anyone the real legacy of Gardasil
& Cervarix, the betrayal of public trust, extending from the highest sectors of Government & the Vaccine Industry to the thousands of clinics & hospitals most families depend on, that has cut into the very heart of the community and
devastated the lives of countless young women
before reaching the prime of their lives.
See entire story at http://sanevax.org/blog/?p=2226
Saturday, February 26, 2011
Monday, February 21, 2011
Merck Funded Study States - Gardasil Equally Effective for Males and Females
SANE Vax, Inc. is Concerned about Missing Data in the Reports
The media went wild last week announcing the report published in the Feb. 3 issue of the New England Journal of Medicine, (NEJM) was funded by the vaccine's maker, Merck & Co., 1 stating Gardasil was 90 percent effective in older teenaged boys and young men.
Gardasil was approved for use for boys ages 9 through 26 in 2009 by the U.S. Food and Drug Administration. U.S. Centers for Disease Control and Prevention advisory panel voted against routine use of the vaccine in boys and men.
Am sure the researchers/marketers at Merck decided a study announcing that Gardasil was equally effective in preventing genital warts would increase uptake/sales of the vaccine. This is a marketing tactic – not a study – and not even an independent study.
The study was conducted on 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18.2.
SANE VAX, Inc. is asking – What about boys ages 9 to 15? Why weren’t they included? By the time a 9 year old reaches the age of 16 – the vaccine will no longer be effective.
SANE Vax wants to know the length of time for the study. Months? Years? Even NEJM does not even report this. Where are the long term results? How can there be any?
Fred Wyand, director of the HPV Resource Center at the American Social Health Association stated; "Studies like this underscore the 'human' in human papillomavirus."3. Well, let’s look at human viruses. They lay dormant, and they mutate. Genital warts come and go in both male and female populations. Viruses are triggered/stimulated by environment and stress – as well as lifestyle. Viral patterns are impossible to predict. The only thing in life that is constant is “change.”
Gardasil is only effective for 5 years. What happens after that? What if the viruses come back in full force? Oh, yeah another vaccine.
Healthy boys? What kind of study is that? Define “healthy.” What about unhealthy boys – boys with pre-existing or a family history of allergies or autoimmune diseases. The same “healthy” demographic was used in the clinical trials for adolescent girls – and there are now 21,292 reported adverse reactions and 93 deaths reported to VAERS.
Why perform a study on another healthy population when the initial study has caused so many injuries to girls ages 9 to 26? SANE Vax Inc. does not think this is science-based medicine at all…. It is more like the fairy tale, “The Emperor has no Clothes.” When are medical consumers and practitioners going to realize that Merck has pulled the wool over our eyes again?
This study would more aptly be titled “One Less Boy to Get Genital Warts.” SANE Vax fears that this campaign will turn into ‘One More Boy Adversely Injured.’ How can the outcome be any different?
SANE Vax Inc. is concerned about the missing data or data not being reported in this study. The line between marketing and science based evidence is getting pretty thin. Medical consumers deserve to have independent studies conducted on the safety and efficacy of any and all medications developed for non-life threatening medical issues. Parents getting the HPV vaccine for their sons need to have the answers to all of these issues for informed consent. The days of blind faith are over.
Sources:
1. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
Supported by Merck and by grants (M01-RR-00079 and UL1 RR024131, to Dr. Palefsky) from the National Center for Research Resources and by a grant (RO1 CA098803, to Dr. Giuliano) from the National Institutes of Health.
Drs. Giuliano, Ferris, Moreira, Penny, and Palefsky report receiving grant support from Merck, either personally or through their institution; Dr. Penny reports receiving grant support from GlaxoSmithKline; Dr. Goldstone reports receiving grant support from Qiagen; Drs. Giuliano, Ferris, Moreira, Hillman, and Chang report receiving speaking fees or fees for board membership from Merck; Dr. Moi reports that his institution has received funding from Merck; Dr. Penny reports having stock or stock options in AstraZeneca; Dr. Palefsky reports receiving consulting fees from GlaxoSmithKline; Drs. Giuliano, Palefsky, Goldstone, Moreira, Moi, and Chang report receiving travel reimbursement from Merck; Dr. Bryan reports having an approved, filed, or pending patent related to subject matter discussed in this article; and Dr. Bryan, Dr. Marshall, Dr. Vuocolo, Dr. Barr, Dr. Haupt, Mr. Radley, and Dr. Guris are employees of Merck and own Merck stock or stock options. No other potential conflict of interest relevant to this article was reported.
2. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
3. MedlinePlus, Feb. 2, 2011, Gardasil Vaccine Guards Against HPV in Boys, http://www.nlm.nih.gov/medlineplus/news/fullstory_108399 ...
For more information, 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 media went wild last week announcing the report published in the Feb. 3 issue of the New England Journal of Medicine, (NEJM) was funded by the vaccine's maker, Merck & Co., 1 stating Gardasil was 90 percent effective in older teenaged boys and young men.
Gardasil was approved for use for boys ages 9 through 26 in 2009 by the U.S. Food and Drug Administration. U.S. Centers for Disease Control and Prevention advisory panel voted against routine use of the vaccine in boys and men.
Am sure the researchers/marketers at Merck decided a study announcing that Gardasil was equally effective in preventing genital warts would increase uptake/sales of the vaccine. This is a marketing tactic – not a study – and not even an independent study.
The study was conducted on 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18.2.
SANE VAX, Inc. is asking – What about boys ages 9 to 15? Why weren’t they included? By the time a 9 year old reaches the age of 16 – the vaccine will no longer be effective.
SANE Vax wants to know the length of time for the study. Months? Years? Even NEJM does not even report this. Where are the long term results? How can there be any?
Fred Wyand, director of the HPV Resource Center at the American Social Health Association stated; "Studies like this underscore the 'human' in human papillomavirus."3. Well, let’s look at human viruses. They lay dormant, and they mutate. Genital warts come and go in both male and female populations. Viruses are triggered/stimulated by environment and stress – as well as lifestyle. Viral patterns are impossible to predict. The only thing in life that is constant is “change.”
Gardasil is only effective for 5 years. What happens after that? What if the viruses come back in full force? Oh, yeah another vaccine.
Healthy boys? What kind of study is that? Define “healthy.” What about unhealthy boys – boys with pre-existing or a family history of allergies or autoimmune diseases. The same “healthy” demographic was used in the clinical trials for adolescent girls – and there are now 21,292 reported adverse reactions and 93 deaths reported to VAERS.
Why perform a study on another healthy population when the initial study has caused so many injuries to girls ages 9 to 26? SANE Vax Inc. does not think this is science-based medicine at all…. It is more like the fairy tale, “The Emperor has no Clothes.” When are medical consumers and practitioners going to realize that Merck has pulled the wool over our eyes again?
This study would more aptly be titled “One Less Boy to Get Genital Warts.” SANE Vax fears that this campaign will turn into ‘One More Boy Adversely Injured.’ How can the outcome be any different?
SANE Vax Inc. is concerned about the missing data or data not being reported in this study. The line between marketing and science based evidence is getting pretty thin. Medical consumers deserve to have independent studies conducted on the safety and efficacy of any and all medications developed for non-life threatening medical issues. Parents getting the HPV vaccine for their sons need to have the answers to all of these issues for informed consent. The days of blind faith are over.
Sources:
1. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
Supported by Merck and by grants (M01-RR-00079 and UL1 RR024131, to Dr. Palefsky) from the National Center for Research Resources and by a grant (RO1 CA098803, to Dr. Giuliano) from the National Institutes of Health.
Drs. Giuliano, Ferris, Moreira, Penny, and Palefsky report receiving grant support from Merck, either personally or through their institution; Dr. Penny reports receiving grant support from GlaxoSmithKline; Dr. Goldstone reports receiving grant support from Qiagen; Drs. Giuliano, Ferris, Moreira, Hillman, and Chang report receiving speaking fees or fees for board membership from Merck; Dr. Moi reports that his institution has received funding from Merck; Dr. Penny reports having stock or stock options in AstraZeneca; Dr. Palefsky reports receiving consulting fees from GlaxoSmithKline; Drs. Giuliano, Palefsky, Goldstone, Moreira, Moi, and Chang report receiving travel reimbursement from Merck; Dr. Bryan reports having an approved, filed, or pending patent related to subject matter discussed in this article; and Dr. Bryan, Dr. Marshall, Dr. Vuocolo, Dr. Barr, Dr. Haupt, Mr. Radley, and Dr. Guris are employees of Merck and own Merck stock or stock options. No other potential conflict of interest relevant to this article was reported.
2. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
3. MedlinePlus, Feb. 2, 2011, Gardasil Vaccine Guards Against HPV in Boys, http://www.nlm.nih.gov/medlineplus/news/fullstory_108399 ...
For more information, 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.
Sunday, February 13, 2011
99 Strains of HPV on the Wall - One MORE GIRL on the Wall
Ninety-nine bottles of beer on the wall, ninety-nine bottles of beer.... Take one down, pass it around, Ninety-eight bottles of beer on the wall.... 99 Strains of HPV on the Wall.... You Take One Down and Pass it Around…. One MORE GIRL on the Wall
FOR IMMEDIATE RELEASE
PRLog (Press Release) – Feb 13, 2011 – By Leslie Carol Botha, Director of SANE VAX, INC.
Ninety-nine bottles of beer on the wall, ninety-nine bottles of beer
Take one down, pass it around, Ninety-eight bottles of beer on the wall.
Sound familiar? 99 Bottles of Beer is a popular traditional U.S. and Canadian song with a repetitive format – easy to memorize - and frequently sung by children on long bus trips, or Scouting outings. The same verse is repeated, each time with one fewer bottle. The song is completed when the singers reach zero.
Could it be that Merck & CO pharmacists are singing 99 Strains of HPV on the Wall as they prepare to manufacture more vaccines targeting more HPV viral strains? And of course the accounting department is humming the same tune as they realize the income potential and enter projected profits from this new revenue stream. And one wonders if Wall Street is also memorizing the song knowing that stock will not only remain stable but potentially soar.
According to an article that appeared in the January 13, 2011 issue of Drug Discovery and Development, Vaccine Markets A Refuge for Big Pharma, http://www.dddmag.com/news-Vaccine-Markets-A-Refuge-for- ... :
…Gardasil, which was approved for the prevention of four strains of HPV (human papillomavirus), is currently being tested for the prevention of nine more strains.
90 Strains of HPV on the Wall
The article also states: “Human vaccines, earlier considered as a low profit yielding business, have transformed into cash cows for global pharmaceutical giants. Patents for human and animal vaccines accepted by European and US patent authorities totaled nearly 250 in 2007. Prophylactic vaccines (intended to prevent cancer from developing in healthy people) represents the biggest earner in the human vaccines market.”
Oh, yes, Big Pharma is singing 99 Strains of HPV on the Wall – all the way to Wall Street.
Meanwhile, SANE Vax, Inc. keeps finding research and documentation on the scientific research behind the vaccines, the faulty trials and the unethical marketing campaigns – that had adolescent girls singing their award –winning “One Less Girl to Get Cervical Cancer” jingle….
Gardasil. Gardasil. Gardasil. Gardasil.
I want to be one less woman who will battle cervical cancer.
One LESS.
One has to admit – the campaign jingle has similar qualities to 99 Bottles of Beer in the Wall – it has a repetitive format and is easy to memorize. Guess Merck’s public relations firm is also singing 99 Strains of HPV on the Wall as they develop more award-winning marketing campaigns.
Unfortunately, one less girl has sadly turned into One More Girl adversely injured. VAERS statistics as of February are: 21,292 girls (20,377) and boys (309) adversely injured, 94 dead; an estimated 1 to 10% of the population reporting.
21,292 HPV Vaccine Adverse Injuries on the Wall - asking when will the jingle end?
Recently, the mother of a 13-year old injured by the vaccine told a SANE Vax member that when she called 1-800 MERCK – the man on the line admitted that not enough clinical trials were conducted on Gardasil and that her daughter was part of a trial. SANE Vax is outraged by this admission. But this is how Pharma operates with all drugs especially for women. Birth control pills, hormone replacement therapy (HRT), and Gardasil are now known as the largest uncontrolled experiments in medical history.
SANE Vax Inc. is determined to prevent Gardasil from being trialed on innocent children. We are proud to be involved in the production of the groundbreaking ONE MORE GIRL documentary along with Truth About Gardasil.org and ThinkExist Productions http://www.kickstarter.com/projects/1995527181/one-more- ....
The time to get involved is now – we need to stop Merck and their 99 Strains of HPV on the Wall thinking until an independent study on the safety and efficacy of Gardasil has been conducted before more HPV-related vaccines are introduced to the market.
Please donate today. The girls injured by the HPV vaccines want to tell their stories to the world to prevent this type of travesty from ever happening again.
99 Strains of HPV on the Wall
You Take One Down and Pass it Around….
One MORE GIRL on the Wall
For more information, 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.
FOR IMMEDIATE RELEASE
PRLog (Press Release) – Feb 13, 2011 – By Leslie Carol Botha, Director of SANE VAX, INC.
Ninety-nine bottles of beer on the wall, ninety-nine bottles of beer
Take one down, pass it around, Ninety-eight bottles of beer on the wall.
Sound familiar? 99 Bottles of Beer is a popular traditional U.S. and Canadian song with a repetitive format – easy to memorize - and frequently sung by children on long bus trips, or Scouting outings. The same verse is repeated, each time with one fewer bottle. The song is completed when the singers reach zero.
Could it be that Merck & CO pharmacists are singing 99 Strains of HPV on the Wall as they prepare to manufacture more vaccines targeting more HPV viral strains? And of course the accounting department is humming the same tune as they realize the income potential and enter projected profits from this new revenue stream. And one wonders if Wall Street is also memorizing the song knowing that stock will not only remain stable but potentially soar.
According to an article that appeared in the January 13, 2011 issue of Drug Discovery and Development, Vaccine Markets A Refuge for Big Pharma, http://www.dddmag.com/news-Vaccine-Markets-A-Refuge-for- ... :
…Gardasil, which was approved for the prevention of four strains of HPV (human papillomavirus), is currently being tested for the prevention of nine more strains.
90 Strains of HPV on the Wall
The article also states: “Human vaccines, earlier considered as a low profit yielding business, have transformed into cash cows for global pharmaceutical giants. Patents for human and animal vaccines accepted by European and US patent authorities totaled nearly 250 in 2007. Prophylactic vaccines (intended to prevent cancer from developing in healthy people) represents the biggest earner in the human vaccines market.”
Oh, yes, Big Pharma is singing 99 Strains of HPV on the Wall – all the way to Wall Street.
Meanwhile, SANE Vax, Inc. keeps finding research and documentation on the scientific research behind the vaccines, the faulty trials and the unethical marketing campaigns – that had adolescent girls singing their award –winning “One Less Girl to Get Cervical Cancer” jingle….
Gardasil. Gardasil. Gardasil. Gardasil.
I want to be one less woman who will battle cervical cancer.
One LESS.
One has to admit – the campaign jingle has similar qualities to 99 Bottles of Beer in the Wall – it has a repetitive format and is easy to memorize. Guess Merck’s public relations firm is also singing 99 Strains of HPV on the Wall as they develop more award-winning marketing campaigns.
Unfortunately, one less girl has sadly turned into One More Girl adversely injured. VAERS statistics as of February are: 21,292 girls (20,377) and boys (309) adversely injured, 94 dead; an estimated 1 to 10% of the population reporting.
21,292 HPV Vaccine Adverse Injuries on the Wall - asking when will the jingle end?
Recently, the mother of a 13-year old injured by the vaccine told a SANE Vax member that when she called 1-800 MERCK – the man on the line admitted that not enough clinical trials were conducted on Gardasil and that her daughter was part of a trial. SANE Vax is outraged by this admission. But this is how Pharma operates with all drugs especially for women. Birth control pills, hormone replacement therapy (HRT), and Gardasil are now known as the largest uncontrolled experiments in medical history.
SANE Vax Inc. is determined to prevent Gardasil from being trialed on innocent children. We are proud to be involved in the production of the groundbreaking ONE MORE GIRL documentary along with Truth About Gardasil.org and ThinkExist Productions http://www.kickstarter.com/projects/1995527181/one-more- ....
The time to get involved is now – we need to stop Merck and their 99 Strains of HPV on the Wall thinking until an independent study on the safety and efficacy of Gardasil has been conducted before more HPV-related vaccines are introduced to the market.
Please donate today. The girls injured by the HPV vaccines want to tell their stories to the world to prevent this type of travesty from ever happening again.
99 Strains of HPV on the Wall
You Take One Down and Pass it Around….
One MORE GIRL on the Wall
For more information, 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.
Tuesday, February 8, 2011
Italian Vaccine Awareness Group Confronts WHO Pandemic Vaccination Policy
By Norma Erickson
For Georgio Tremante, there is no vaccine controversy, only facts. Georgio and his family lost a son in 1971, another in 1980, and have a third child who was left a quadriplegic with respiratory insufficiency after administration of the Sabin polio vaccine.
His son, Alberto, has had to endure years of hospitalization attached to a respirator because he could no longer breathe on his own. Georgio believes Alberto was saved to show the world an inconvenient truth the pharmaceutical companies would like to bury; vaccines can, and do kill and maim innocent children.
This family has experienced the persecution that comes from trying to expose the truth about vaccination risks. They have maintained their mission in spite of pressure from pharmaceutical companies, medical authorities and government agencies. They have continued to do their research and broadcast the facts about vaccination risks in spite of all they have had to endure. View the results of this family and others like them throughout Italy on a website called, A.L.V. “Holocaust” caused by vaccination practices.
As a result of this group’s efforts, a petition is being circulated calling for an end to mandatory and/or forced vaccinations. They are asking government officials around the world to take a serious look at the science behind vaccination practices and re-assess the safety and efficacy of current vaccination policies and programs. An excerpt from their petition says it all:
“We, the undersigned, as free men and women, we do not recognize the authority of the World Health Organization (WHO) that the general mandate for us to immunization. Our bodies are sovereign territory and are subject to our exclusive self-determination. Any attempt to breach this trust must be interpreted as a violation of a fundamental right.”
The A.L.V. is not alone in their belief. Vaccine safety groups from around the world are united in their efforts to expose the potential risks involved with vaccines and current vaccination practices. Consider some of the events from around the world regarding vaccines:
February 2009, two girls are hospitalized in Spain after Gardasil injections, prompting a recall of 76,000 doses of Merck’s ‘cervical cancer’ vaccine.
April 2010, India halts HPV vaccine demonstration projects as a result of health advocates’ concerns about HPV vaccine safety and ethical violations by the organizations conducting the ‘projects.’
April 2010, Bhutan calls an immediate halt to their HPV vaccination program, scheduled to begin in May, in response to the investigation in India.
August 2010, French authorities ban advertising Gardasil® as a preventive measure for cervical cancer.
September 2010, Scottish health authorities come under fire from vaccine safety advocates for failure to disclose potential risks involved with HPV vaccines.
October 2010, Irish mothers unite to get the truth out about potential risk of Gardasil®.
October 2010, in the United States, SaneVax Inc. requests the FDA rescind the approval of Gardasil® until it is proven safe and effective.
January 2011, British Society for Ecological Medicine organizes a medical conference entitled, “The Health Hazards of Prevention – Vaccinations and Pharmacoprophylaxis.”
These are but a few of the significant developments in the vaccine safety advocate community during the last year.
The World Health Organization assessed the situation properly when they said governments, pharmaceutical companies and health officials need to address parental concerns about vaccine safety.
Parents around the world are not going to sit quietly by as their children are injured or killed because of public policy. Their concerns do, indeed, need to be addressed – not with rhetoric and platitudes – but with sound, scientific evidence.
Please visit our site at http://sanevax.org/
For Georgio Tremante, there is no vaccine controversy, only facts. Georgio and his family lost a son in 1971, another in 1980, and have a third child who was left a quadriplegic with respiratory insufficiency after administration of the Sabin polio vaccine.
His son, Alberto, has had to endure years of hospitalization attached to a respirator because he could no longer breathe on his own. Georgio believes Alberto was saved to show the world an inconvenient truth the pharmaceutical companies would like to bury; vaccines can, and do kill and maim innocent children.
This family has experienced the persecution that comes from trying to expose the truth about vaccination risks. They have maintained their mission in spite of pressure from pharmaceutical companies, medical authorities and government agencies. They have continued to do their research and broadcast the facts about vaccination risks in spite of all they have had to endure. View the results of this family and others like them throughout Italy on a website called, A.L.V. “Holocaust” caused by vaccination practices.
As a result of this group’s efforts, a petition is being circulated calling for an end to mandatory and/or forced vaccinations. They are asking government officials around the world to take a serious look at the science behind vaccination practices and re-assess the safety and efficacy of current vaccination policies and programs. An excerpt from their petition says it all:
“We, the undersigned, as free men and women, we do not recognize the authority of the World Health Organization (WHO) that the general mandate for us to immunization. Our bodies are sovereign territory and are subject to our exclusive self-determination. Any attempt to breach this trust must be interpreted as a violation of a fundamental right.”
The A.L.V. is not alone in their belief. Vaccine safety groups from around the world are united in their efforts to expose the potential risks involved with vaccines and current vaccination practices. Consider some of the events from around the world regarding vaccines:
February 2009, two girls are hospitalized in Spain after Gardasil injections, prompting a recall of 76,000 doses of Merck’s ‘cervical cancer’ vaccine.
April 2010, India halts HPV vaccine demonstration projects as a result of health advocates’ concerns about HPV vaccine safety and ethical violations by the organizations conducting the ‘projects.’
April 2010, Bhutan calls an immediate halt to their HPV vaccination program, scheduled to begin in May, in response to the investigation in India.
August 2010, French authorities ban advertising Gardasil® as a preventive measure for cervical cancer.
September 2010, Scottish health authorities come under fire from vaccine safety advocates for failure to disclose potential risks involved with HPV vaccines.
October 2010, Irish mothers unite to get the truth out about potential risk of Gardasil®.
October 2010, in the United States, SaneVax Inc. requests the FDA rescind the approval of Gardasil® until it is proven safe and effective.
January 2011, British Society for Ecological Medicine organizes a medical conference entitled, “The Health Hazards of Prevention – Vaccinations and Pharmacoprophylaxis.”
These are but a few of the significant developments in the vaccine safety advocate community during the last year.
The World Health Organization assessed the situation properly when they said governments, pharmaceutical companies and health officials need to address parental concerns about vaccine safety.
Parents around the world are not going to sit quietly by as their children are injured or killed because of public policy. Their concerns do, indeed, need to be addressed – not with rhetoric and platitudes – but with sound, scientific evidence.
Please visit our site at http://sanevax.org/
Wednesday, February 2, 2011
Gardasil Vaccination: Evaluating The Risks Versus Benefits
Are the risks of adverse events related to GARDASIL the HPV Vaccine greater than the benefits? As the adverse events reported in VAERS escalate and the death count increases, parents should investigate the benefits before deciding to vaccinate.
Feb 02, 2011 – All drugs are associated with some risks of adverse reactions and vaccines are no exception. In weighing risks versus benefits, one has to keep in mind that vaccines represent a special category of drugs since they are generally given to healthy individuals.
If there are uncertain benefits from a vaccine, only a small level of risk of harmful effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated. Here I review the current evidence which indicates that the former case applies to Gardasil, the quadrivalent human papillomavirus (qHPV) vaccine:
1) The efficacy of Gardasil in preventing cervical cancer has not been demonstrated and the marketing campaign has been misleading. The efficacy of Gardasil remains unsubstantiated since the vaccine hasn’t been adequately tested on the primary age group to which it is currently given.
Merck promoted Gardasil primarily as a vaccine against cervical cancer, rather than promoting it as a vaccine against HPV infection or sexually transmitted diseases 1.
According to recent reports published in two highly respected scientific journals, Nature Biotechnology and Journal of American Medical Association (JAMA):
“Most genital infections are asymptomatic and resolve spontaneously, but the virus can persist and cause precancerous lesions that can become malignant over the subsequent 20-30 years.“ (Nature Biotechnology, 2007 2)
“So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls a vaccine that partly prevents infection caused by a sexually transmitted disease (HPV infection), an infection that in a few cases will cause cancer 20 to 40 years from now? (JAMA, 2009 3).
The fact is that malignant cervical cancer takes decades to develop 2 3 and yet the longest clinical trial on Gardasil was only four years in duration 4. In other words, Gardasil was never shown to prevent cervical cancer [emphasis added]. Furthermore, in all clinical trials conducted by Merck the cervical intraepithelial neoplasia (CIN) 2/3 precancerous lesion was used as the efficacy endpoint for evaluating the Gardasil 4. What is the problem with using the CIN 2/3 lesion as the standard for efficacy? First, if the marketing claim for Gardasil is that the vaccine “protects against cervical cancer” 1 2 5, then cervical cancer should have been used as the endpoint for efficacy, not a surrogate marker such as a CIN 2/3 precancerous lesion [emphasis added].
Second, in the natural course of cervical cancer, only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions and only a small fraction of CIN 3 lesions will eventually progress to cervical cancer 6.
Furthermore, even CIN 3 lesions are heterogeneous (there are early small lesions and old advanced lesions and we do not know what proportion of the small lesions, which serve as clinical endpoints in current studies, would persist to become large, advanced CIN3 lesions) 7.
Therefore, in any female population (and that includes those who have undergone Gardasil clinical trials) there are many more CIN 2 lesions than a combination of CIN 3 lesions and cervical cancers. As a result, the vast majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy, and listed in Merck‟s report to FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8), must have been CIN 2 lesions.
In a review of the literature from 1950-1992, it was noted that 60% of CIN 1 lesions regressed, 30% persisted, 10% progressed to CIN 3, and only 1% progressed to invasive cancer. The corresponding approximations for CIN 2 were 40%, 40%, 20%, and 5%, respectively. The likelihood of CIN 3 regressing was 33% and that of progressing to invasive cancer was greater than 12% 6.
The author of the study, Andrew G Östör, MD, from the Departments of Obstetrics and Gynaecology and Pathology, University of Melbourne noted 6:
“It is obvious from the above figures that the probability of an atypical epithelium becoming invasive increases with the severity of the atypia, but does not occur in every case. Even the higher degrees of atypia may regress in a significant proportion of cases. As morphology by itself does not predict which lesion will progress or regress, future efforts should seek factors other than morphological to determine the prognosis in individual patients.” [emphasis added]
The above remark leads us to a third reason why a surrogate morphological marker is not an adequate endpoint for assessing the efficacy of cervical cancer vaccines 9:
“CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less than-perfect representation of the underlying disease state.” [empahsis added]
Furthermore, the same report by the National Cancer Institute (NCI 9) states that:
“That CIN2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error…”
Finally, according to second report by the NCI 10:
“Approximately 40% of undiagnosed CIN 2 will regress over two years” (this also precisely corroborates the findings of the study by Östör)
Gardasil is marketed as the vaccine that prevents cervical cancer 1 2 5.This statement is incorrect. Based on the above NCI findings, we can conclude that the data presented in the VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8 only supports the claim that Gardasil can prevent “an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer” - about half of which are self-reversing to normal cases and not reflect actual cervical cancer. [emphasis added]
There was yet another important oversight in assessing the efficacy of Gardasil. Most cervical cancers are believed to be linked to infection with genital HPV types 6, 11, 16, and 18 2 3 11. According to NCI, the only reliable HPV genotyping method is a “PCR system with short target sequences” 12 or alternatively, “ ’sentinel-base’ genotyping by PCR” 13 Ironically, these HPV genotyping methods were never used to determine the HPV type associated with precancerous lesions in the clinical trials for evaluation of the efficacy of Gardasil to prevent type-specific HPV infections.
2) Cervical cancer is a rare disease in developed countries which invalidates the recommendations for universal immunization with any HPV vaccine. The incidence of cervical cancer has dropped substantially since implementation of regular Pap screening procedures. Currently, in the US, the death rate from cervical cancer (2.4/100,000 women) is lower than the rate of reported serious adverse events, including death, from Gardasil (3.34/100,000 doses distributed)
The severity of cervical cancer should not be undermined. Advanced cervical cancer is a deadly disease, especially in areas where the resources and infrastructure to fully implement
To continue reading the story, go to http://sanevax.org/news-blog/?p=1353.
Story by Lucija Tomljenovic, PhD, contributing author for SANEVAX, INC.
# # #
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.
Feb 02, 2011 – All drugs are associated with some risks of adverse reactions and vaccines are no exception. In weighing risks versus benefits, one has to keep in mind that vaccines represent a special category of drugs since they are generally given to healthy individuals.
If there are uncertain benefits from a vaccine, only a small level of risk of harmful effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated. Here I review the current evidence which indicates that the former case applies to Gardasil, the quadrivalent human papillomavirus (qHPV) vaccine:
1) The efficacy of Gardasil in preventing cervical cancer has not been demonstrated and the marketing campaign has been misleading. The efficacy of Gardasil remains unsubstantiated since the vaccine hasn’t been adequately tested on the primary age group to which it is currently given.
Merck promoted Gardasil primarily as a vaccine against cervical cancer, rather than promoting it as a vaccine against HPV infection or sexually transmitted diseases 1.
According to recent reports published in two highly respected scientific journals, Nature Biotechnology and Journal of American Medical Association (JAMA):
“Most genital infections are asymptomatic and resolve spontaneously, but the virus can persist and cause precancerous lesions that can become malignant over the subsequent 20-30 years.“ (Nature Biotechnology, 2007 2)
“So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls a vaccine that partly prevents infection caused by a sexually transmitted disease (HPV infection), an infection that in a few cases will cause cancer 20 to 40 years from now? (JAMA, 2009 3).
The fact is that malignant cervical cancer takes decades to develop 2 3 and yet the longest clinical trial on Gardasil was only four years in duration 4. In other words, Gardasil was never shown to prevent cervical cancer [emphasis added]. Furthermore, in all clinical trials conducted by Merck the cervical intraepithelial neoplasia (CIN) 2/3 precancerous lesion was used as the efficacy endpoint for evaluating the Gardasil 4. What is the problem with using the CIN 2/3 lesion as the standard for efficacy? First, if the marketing claim for Gardasil is that the vaccine “protects against cervical cancer” 1 2 5, then cervical cancer should have been used as the endpoint for efficacy, not a surrogate marker such as a CIN 2/3 precancerous lesion [emphasis added].
Second, in the natural course of cervical cancer, only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions and only a small fraction of CIN 3 lesions will eventually progress to cervical cancer 6.
Furthermore, even CIN 3 lesions are heterogeneous (there are early small lesions and old advanced lesions and we do not know what proportion of the small lesions, which serve as clinical endpoints in current studies, would persist to become large, advanced CIN3 lesions) 7.
Therefore, in any female population (and that includes those who have undergone Gardasil clinical trials) there are many more CIN 2 lesions than a combination of CIN 3 lesions and cervical cancers. As a result, the vast majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy, and listed in Merck‟s report to FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8), must have been CIN 2 lesions.
In a review of the literature from 1950-1992, it was noted that 60% of CIN 1 lesions regressed, 30% persisted, 10% progressed to CIN 3, and only 1% progressed to invasive cancer. The corresponding approximations for CIN 2 were 40%, 40%, 20%, and 5%, respectively. The likelihood of CIN 3 regressing was 33% and that of progressing to invasive cancer was greater than 12% 6.
The author of the study, Andrew G Östör, MD, from the Departments of Obstetrics and Gynaecology and Pathology, University of Melbourne noted 6:
“It is obvious from the above figures that the probability of an atypical epithelium becoming invasive increases with the severity of the atypia, but does not occur in every case. Even the higher degrees of atypia may regress in a significant proportion of cases. As morphology by itself does not predict which lesion will progress or regress, future efforts should seek factors other than morphological to determine the prognosis in individual patients.” [emphasis added]
The above remark leads us to a third reason why a surrogate morphological marker is not an adequate endpoint for assessing the efficacy of cervical cancer vaccines 9:
“CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less than-perfect representation of the underlying disease state.” [empahsis added]
Furthermore, the same report by the National Cancer Institute (NCI 9) states that:
“That CIN2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error…”
Finally, according to second report by the NCI 10:
“Approximately 40% of undiagnosed CIN 2 will regress over two years” (this also precisely corroborates the findings of the study by Östör)
Gardasil is marketed as the vaccine that prevents cervical cancer 1 2 5.This statement is incorrect. Based on the above NCI findings, we can conclude that the data presented in the VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8 only supports the claim that Gardasil can prevent “an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer” - about half of which are self-reversing to normal cases and not reflect actual cervical cancer. [emphasis added]
There was yet another important oversight in assessing the efficacy of Gardasil. Most cervical cancers are believed to be linked to infection with genital HPV types 6, 11, 16, and 18 2 3 11. According to NCI, the only reliable HPV genotyping method is a “PCR system with short target sequences” 12 or alternatively, “ ’sentinel-base’ genotyping by PCR” 13 Ironically, these HPV genotyping methods were never used to determine the HPV type associated with precancerous lesions in the clinical trials for evaluation of the efficacy of Gardasil to prevent type-specific HPV infections.
2) Cervical cancer is a rare disease in developed countries which invalidates the recommendations for universal immunization with any HPV vaccine. The incidence of cervical cancer has dropped substantially since implementation of regular Pap screening procedures. Currently, in the US, the death rate from cervical cancer (2.4/100,000 women) is lower than the rate of reported serious adverse events, including death, from Gardasil (3.34/100,000 doses distributed)
The severity of cervical cancer should not be undermined. Advanced cervical cancer is a deadly disease, especially in areas where the resources and infrastructure to fully implement
To continue reading the story, go to http://sanevax.org/news-blog/?p=1353.
Story by Lucija Tomljenovic, PhD, contributing author for SANEVAX, INC.
# # #
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.
Subscribe to:
Posts (Atom)