By Barbara Loe Fisher
During the past decade, families in the United Kingdom, Canada and America have witnessed the demonization of brave doctors and parents of vaccine injured children. It has been both sickening and frightening to watch physicians and some journalists engage in a relentless persecution of Dr. Andrew Wakefield, who first published research in 1998 examining the potential association between MMR vaccine and autism. It has become obvious that their goal is to turn him into a horrible warning to any physician who dares to investigate vaccine injury, especially regressive autism. Not satisfied with trying to destroy the doctor, who refuses to recant and defends pursuit of scientific truth, forced vaccination proponents are now acting to kill not only freedom of thought and scientific inquiry but also freedom of speech and informed consent to voluntary use of vaccines.
Exactly what was the sin that British gastroenterologist, Andrew Wakefield, M.D. committed in 1998 that made him a target for persecution? He dared to hypothesize that a subset of children may be vulnerable, for immunological reasons, to developing vaccine strain measles virus infection triggered by MMR vaccination that causes acute and chronic inflammation in the body and can lead to persistent health problems, including a form of inflammatory bowel disease and brain dysfunction manifested by autism. It is hardly a radical hypothesis. Since smallpox vaccine, evidence that vaccines can cause acute and chronic immune-mediated inflammation in the brain and other parts of the body has been well documented in the medical literature (A literature review of evidence is featured in the 2008 book "Vaccines, Autism & Chronic Inflammation: The New Epidemic.")
What has so infuriated the vaccine establishment is that the live vaccine strain viral infection mechanism not only has strong biological plausibility but has been acknowledged by physicians and scientists for decades, particularly with regard to live vaccine strain paralytic polio and death from persistent vaccine strain measles infection. In fact, vaccine strain viral infection has been associated with not only live virus polio and measles vaccine, but also with live BCG, chicken pox and, now, rotavirus vaccine. A late-breaking report at the annual meeting of the American Academy of Allergy, Asthma and Immunology discusses the development of live vaccine strain rotavirus infection following rotavirus vaccination in children with immune deficiencies. The human-bovine genetic hybrid vaccine, Rotateq, for which Paul Offit, M.D.is a co-patent holder, caused diarrhea, acidosis, failure to thrive, dehydration and shock in two babies with undiagnosed immune system dysfunction within two months of vaccination. Molecular analysis of rotavirus isolates taken from the babies indicated that the rotavirus vaccine strains mutated.
All of the biological mechanisms involved in vaccine induced neuroimmune dysfunction and the biological high risk factors for suffering vaccine injury and death have not been scientifically investigated, and few methodologically sound vaccine risk studies get funded and published in the medical literature, which makes the attempt by doctors and scientists to block the search for scientific truth and limit the public's right to know and act even more repulsive. On February 26, 2009, bully boy Dr. David Salisbury, the Director of Immunization at the UK Department of Health, threatened The One Click Group, a UK internet based news service founded by Jane Bryant, that he would sue them for publishing facts about MMR vaccine risks unless One Click removes the information he wants censored and apologizes for publishing it without his permission.
On March 7, a British newspaper reported that no longer would duly elected legislators have ultimate responsibility for saying "yes" or "no" to new vaccine mandates but that the power to force vaccine use in Britain would be wielded by unelected physicians and scientists, who are members of the government's Joint Committee on Vaccination and Immunisation (JCVI). A day later, another British newspaper reported that many members of the JCVI have financial ties to vaccine manufacturers, including Merck, GlaxoSmithKline, Sanofi Pasteur and Novartis and that the JVCI has been involved in past attempts to hide evidence that MMR vaccine can cause brain inflammation and permanent brain damage.
On March 12, a reporter writing for the Canadian Broadcasting Corporation called for a "legalized type of censorship," a ban on talking about the "vaccine/autism hypothesis" because he pronounced it "the modern equivalent of falsely crying 'fire' in a crowded theatre." Pointing to opinions issued by three individuals working for the U.S. Court of Claims denying federal compensation to MMR vaccine injured autistic children as if he was referring to the tablet Moses inscribed with the Ten Commandments, bully boy Stephen Strauss demanded that legislatures "draft a law or courts should hand down a ruling prohibiting anti-vaccine promoters from claiming that vaccines cause autism."
This rabid foaming at the mouth, which is being exhibited by physicians and journalists promoting forced vaccination, would be comical if it wasn't for the decidedly Stalinist bent to their rants. Bully boys always choose to use fear and intimidation to try to control the thoughts and actions of others and those calling for censorship and punishment for exercising freedom of thought, expression and informed consent to vaccination are no exception.
But educated citizens committed to defending their right to know and freedom to decide, are acting to protect themselves. Following is listing of events in New Jersey and New York which promote vaccine education and freedom to choose:
Merck Write-In Campaign: Sponsored by the New Jersey Coalition for Vaccination Choice (NJCVC ), an Action Alert that was also published by Age of Autism, urges vaccine maker Merck to continue to market the individual measles, mumps and rubella vaccines rather than forcing parents to give their children the combination MMR vaccine. Write-In Campaign coordinator Louise Habakus says "Let's send a strong message from parents that Merck must resume manufacturing the monovalent vaccines." Click here for more information and a sample letter.
NY Vaccine Mandates & Exemption Action: New York has pending legislation to mandate HPV vaccine (A778) and Hepatitis A vaccine (A6008) as well as legislation protecting medical exemptions (A880/S2339); religious exemptions (A883/S2338); and adding philosophical exemption (A4886/S2337) to vaccine laws. Parents are organizing vaccine education campaigns for legislators and the public. Contact New Yorkers for Vaccination Information Choice (NYVIC)
Learn how important it is to fight for the right to exercise vaccine exemptions by watching an arrogant New York state attorney grill NY Mom Rita Palma about her religious beliefs concerning vaccination. For more information go to www.MyKidsM yChoice.com
March 24: In Albany, NY, the Autism Action Coalition (AAC) holds the First Autism Advocacy Day that will include a 10:30 a.m. rally and Noon meeting with state legislators to advocate for autism support services and the need for a philosophical exemption to vaccination. Click here for more information about the rally and day's events.
March 25: In New York City at 6:30 p.m., pediatrician Lawrence B. Palevsky, M.D. gives a three hour presentation on the safety and efficacy of vaccines. For more information and tickets, go to www.drpalevsky.com
Americans cannot sit back and assume that we will always be free to make choices about use of pharmaceutical products, including vaccines, that physicians and government officials invoking the "greater good" direct us to use. Censorship in science and on the internet combined with forced medical risk taking is a prescription for tyranny and will become a reality if we don't become activist citizens and stop the bully boys from taking away our right to know and freedom to choose. For more information, go to www.NVIC.org.
Talking Vaccine Science with Government: Why Do It?
by Barbara Loe Fisher
After the historic election in November that saw Barack Obama elected President, I wondered what he and his Administration would do about addressing the question that is on the minds of many parents: Why are so many vaccinated children today chronically ill, suffering with learning disabilities, ADD/ADHD, autism, asthma, diabetes and other brain and immune system problems? Would the Obama Administration acknowledge the importance of looking at whether national vaccine policies are having an unintended negative effect on a growing number of children and adopt a robust vaccine safety research agenda to answer outstanding questions?
Part of the answer came one day after the President took office, on January 21, when he sent a memo to the heads of all federal agencies and told them "My Administration is committed to creating an unprecedented level of openness in Government. We will work together to ensure the public trust and establish a system of transparency, public participation and collaboration."
The door is opening and there is a lot of work to be done. Concerned citizens getting involved will keep the participatory democracy process and work products truly transparent, collaborative and meaningful.
This Monday, March 16, there will be an open meeting in Washington, D.C. sponsored by the CDC to get input from the public about the kinds of scientific studies that should be included in the national vaccine safety research agenda.
At stake is a proposal by a vaccine stakeholder Writing Group that met in Salt Lake City last month to look at whether a study comparing the health of vaccinated and unvaccinated children should be included that evaluates whether there are pathological differences in brain and immune system development and function and whether there are biological high risk factors that place some children at higher risk than others for suffering vaccine reactions.
If you want to weigh in, this is an opportunity to make your voice heard either by showing up at the meeting, participating online or by conference call.
Who: National Vaccine Advisory Committee
Where: Department of Health and Human Services; Hubert H. Humphrey Building, Room 800; 200 Independence Avenue, S.W., Washington, D.C. 20201
Why: To talk about the draft vaccine research agenda of CDC's Immunization Safety Office (ISO). Draft documents prepared by the vaccine stakeholder Writing Group that identify potential gaps in the ISO draft research agenda and proposes prioritization criteria for the agenda will be reviewed. These documents are available at: http://www.hhs.gov/nvpo/nvac/PublicEngageme nt.html and include Writing Group Draft Statements on (1) Outcomes; (2) Gaps in the Research Agenda; and (3) Criteria for Assessing ISO Research Topic Priorities. Participants at the March 16 meeting will be asked to comment on potential gaps in the draft agenda and options for developing research priorities.
How to Attend: The meeting will be webcast and audio conferencing is available. Contact Kirsten Vannice (kirsten.vannice@hhs.gov if you want to come to the meeting or be hooked up by computer or phone. Draft agenda, call-in numbers, a link to the webcast and additional materials will be provided to registered participants and posted on the NVPO website in advance of the meeting.
Importance of Meeting: The government's scientific research agenda to investigate vaccine associated brain and immune system dysfunction among children is of great interest to a growing number of Americans living in every state who have children with learning disabilities, ADD/ADHD, autism, asthma, diabetes and other kinds of chronic illness.
The CDC held public engagement meetings in Birmingham, Ashland and Indianapolis in the past few months to ask citizens about their vaccine safety concerns. A vaccine stakeholder meeting in Salt Lake City Feb. 20-21 was also held, coordinated and facilitated by The Keystone Center, to create a suggested framework for setting national vaccine safety research priorities.
There are individuals, special interest groups and corporations opposed to a robust scientific research agenda addressing vaccine safety concerns that involve input from and participation by the public. Those who support both the participatory democracy approach to government policymaking, which is defined by government transparency and collaboration with the people, should consider attending in person, online or on the telephone to voice their concerns.
One way Americans can change government and government policies is by becoming activist citizens advocating for constructive change. President Obama's call for transparency, accountability and public engagement is an opportunity to stand up and make a difference by helping to reform government policy, such as vaccine policy, which affects the health of our children and grandchildren.
The power does belong to the people if the people will stand up and exercise it wisely.
After the historic election in November that saw Barack Obama elected President, I wondered what he and his Administration would do about addressing the question that is on the minds of many parents: Why are so many vaccinated children today chronically ill, suffering with learning disabilities, ADD/ADHD, autism, asthma, diabetes and other brain and immune system problems? Would the Obama Administration acknowledge the importance of looking at whether national vaccine policies are having an unintended negative effect on a growing number of children and adopt a robust vaccine safety research agenda to answer outstanding questions?
Part of the answer came one day after the President took office, on January 21, when he sent a memo to the heads of all federal agencies and told them "My Administration is committed to creating an unprecedented level of openness in Government. We will work together to ensure the public trust and establish a system of transparency, public participation and collaboration."
The door is opening and there is a lot of work to be done. Concerned citizens getting involved will keep the participatory democracy process and work products truly transparent, collaborative and meaningful.
This Monday, March 16, there will be an open meeting in Washington, D.C. sponsored by the CDC to get input from the public about the kinds of scientific studies that should be included in the national vaccine safety research agenda.
At stake is a proposal by a vaccine stakeholder Writing Group that met in Salt Lake City last month to look at whether a study comparing the health of vaccinated and unvaccinated children should be included that evaluates whether there are pathological differences in brain and immune system development and function and whether there are biological high risk factors that place some children at higher risk than others for suffering vaccine reactions.
If you want to weigh in, this is an opportunity to make your voice heard either by showing up at the meeting, participating online or by conference call.
Who: National Vaccine Advisory Committee
Where: Department of Health and Human Services; Hubert H. Humphrey Building, Room 800; 200 Independence Avenue, S.W., Washington, D.C. 20201
Why: To talk about the draft vaccine research agenda of CDC's Immunization Safety Office (ISO). Draft documents prepared by the vaccine stakeholder Writing Group that identify potential gaps in the ISO draft research agenda and proposes prioritization criteria for the agenda will be reviewed. These documents are available at: http://www.hhs.gov/nvpo/nvac/PublicEngageme nt.html and include Writing Group Draft Statements on (1) Outcomes; (2) Gaps in the Research Agenda; and (3) Criteria for Assessing ISO Research Topic Priorities. Participants at the March 16 meeting will be asked to comment on potential gaps in the draft agenda and options for developing research priorities.
How to Attend: The meeting will be webcast and audio conferencing is available. Contact Kirsten Vannice (kirsten.vannice@hhs.gov if you want to come to the meeting or be hooked up by computer or phone. Draft agenda, call-in numbers, a link to the webcast and additional materials will be provided to registered participants and posted on the NVPO website in advance of the meeting.
Importance of Meeting: The government's scientific research agenda to investigate vaccine associated brain and immune system dysfunction among children is of great interest to a growing number of Americans living in every state who have children with learning disabilities, ADD/ADHD, autism, asthma, diabetes and other kinds of chronic illness.
The CDC held public engagement meetings in Birmingham, Ashland and Indianapolis in the past few months to ask citizens about their vaccine safety concerns. A vaccine stakeholder meeting in Salt Lake City Feb. 20-21 was also held, coordinated and facilitated by The Keystone Center, to create a suggested framework for setting national vaccine safety research priorities.
There are individuals, special interest groups and corporations opposed to a robust scientific research agenda addressing vaccine safety concerns that involve input from and participation by the public. Those who support both the participatory democracy approach to government policymaking, which is defined by government transparency and collaboration with the people, should consider attending in person, online or on the telephone to voice their concerns.
One way Americans can change government and government policies is by becoming activist citizens advocating for constructive change. President Obama's call for transparency, accountability and public engagement is an opportunity to stand up and make a difference by helping to reform government policy, such as vaccine policy, which affects the health of our children and grandchildren.
The power does belong to the people if the people will stand up and exercise it wisely.
Vaccine Science: A Search for Truth
by Barbara Loe Fisher
February 2009 turned out to be a month when vaccine science was put on trial in the U.S. Court of Claims in Washington, D.C., in mainstream media and on the internet, in the British Medical Journal and in vaccine safety research initiatives by the U.S. Department of Health and Human Services. Despite concerted efforts by some to close the book on vaccine-related brain dysfunction that includes autism spectrum disorders, it is clear that the search for scientific truth will continue as it always must in science.
The month began with a Feb. 6 CBS-TV news report on new information released by NVIC on serious Gardasil risks, which was followed within 48 hours by a highly orchestrated and very well publicized transatlantic attack on MMR vaccine researcher Andrew Wakefield, M.D. in preparation for a Feb. 12 public announcement by the U.S. Court of Claims denying federal compensation to three children, who regressed into autism after MMR vaccination. The same day that three autistic children were denied federal compensation in the U.S., the British Medical Journal published a Cochrane Collaboration analysis revealing that influenza vaccine studies are more likely to be published in medical journals and rated highly if they are funded by pharmaceutical companies, even when the vaccine studies are of poor quality.
The month ended on a hopeful note with a joint statement finalized February 27 by a CDC- sponsored vaccine safety writing workgroup that asked the National Vaccine Advisory Committee (NVAC) to consider conducting more research into the vaccine schedule, whether some children are biologically at greater risk than others for suffering vaccine reactions and whether there are differences in immune and brain function between vaccinated vs. unvaccinated children. The proposal to investigate adding these kinds of studies to the national vaccie safety research agenda, if approved by the entire NVAC, would include identification of biological markers and biological differences, if any, in brain and immune system function between vaccinated and unvaccinated children.
In a questionable "class action" type Omnibus hearing process, whereby the U.S. Department of Justice allowed (encouraged?) some 5,000 cases of regressive autism after vaccination to be lumped together and argued by plaintiff's lawyers using two narrow biological mechanism hypotheses involving thimerosal and MMR vaccine, the first three Omnibus cases were rejected by three special masters employed by the U.S. Court of Claims. The Court relied heavily on epidemiological studies published in medical journals - the same medical journals which give preferential treatment to methodologically flawed studies funded by vaccine manufacturers.
In a distortion of the National Childhood Vaccine Injury Act that created the Vaccine Injury Compensation Program (VICP), the Court appears to have inappropriately assumed authority that Congress never gave them in 1986: to act as judge and jury on a global scientific question yet to be definitively answered by medical science. The special masters of the Court are neither qualified nor was the 1986 law intended to give them the power to determine the scientific validity of whether vaccines can ever cause autism or any other permanent injury. The special masters were supposed to be administrators and facilitators for providing no-fault, non adversarial federal vaccine injury compensation in lieu of a civil lawsuit against vaccine manufacturers and physicians. In fulfilling that responsibility, these administrators for the Court were supposed to "presume" causation in the absence of a more biologically plausible explanation for the child's injuries or death.
The tragic consequence of this and other politically motivated distortions of the 1986 law is that thousands of previously healthy children, who suffered brain injury and regressed into autism after vaccination, are now in danger of having their vaccine injury claims prejudicially judged and dismissed without being given their own day in "vaccine court." Most of these children certainly will never have their day in civil court in front of a jury of their peers.
Vaccine injury cases are each different due to biodiversity, individual extenuating circumstances, vaccines or combination of vaccines given, plus a number of biological mechanisms for vaccine injury and death - known and unknown - that can be argued in an individual case. This means that an individualized, not a group, approach to obtaining and awarding federal vaccine injury compensation is required. A case in point is the Feb. 20 release of a U.S. Court of Claims compensation award to a child who suffered brain inflammation (Acute Disseminated Encephalomyelitis) after MMR vaccination and was left with permanent brain dysfunction, including autism.
There have been other awards in the VICP for cases of DPT and DTaP vaccine induced brain inflammation/encephalopathy that caused permanent brain injury, including autism. A long acknowledged serious complication of both infectious disease and vaccination is acute brain inflammation that can cause chronic brain dysfunction manifested in many different ways. (See Vaccines, Autism & Chronic Inflammation: The New Epidemic)
So, despite the concerted efforts by some to misrepresent the legal and political significance of recent U.S. Court of Claims judgments in order to dismiss vaccine associated autism as having no scientific validity, vaccine safety advocates have pledged to continue calls for credible scientific investigation into vaccine related neuroimmune dysfunction. Andrew Wakefield is demonstrating the same resolve by taking action to clear his name from libelous and slanderous charges by an obsessed British newspaper reporter who is behaving more like a jilted suitor-turned stalker than a credible journalist. Needless to say, Dr. Wakefield and others will continue scientific research into vaccine associated brain and immune system dysfunction in a dedicated effort to add to the base of scientific knowledge about vaccination.
Finally, it is a hopeful sign that at the end of February a joint statement was signed by a diverse group of vaccine stakeholders who met in Salt Lake City Feb. 20-21, 2009 to discuss national vaccine safety research priorities. Assisted by expert facilitators from The Keystone Center, the CDC sponsored Vaccine Safety Writing Group included federal and state public health officials, pediatricians, infectious disease specialists, immunologists, vaccine developers, health policy analysts, child vaccine advocates and representatives from vaccine safety and autism groups including NVIC, SafeMinds and Autism Speaks.
The vaccine stakeholder group stated that the National Vaccine Advisory Committee (NVAC) should "charge an expert panel with evaluating study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. This draft charge is responsive to issues raised at community meetings in Alabama, Oregon and Indiana as well as the Interagency Autism Coordinating Committee request for collaboration with the National Vaccine Program Office."
The group further stated that :
"There is a strong desire to study the health impact of the immunization schedule, potentially through a 'vaccinated vs. unvaccinated study.' Outcomes to assess include biomarkers of immunity and metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities. The inclusion of autism as an outcome is desired."
The meeting of vaccine stakeholders was the latest in a series of government/citizen encounters that began in 2002 in a CDC-sponsored participatory democracy initiative called the Vaccine Policy Analysis Collaborative. Although the original vaccine stakeholder group dissolved in 2005, the CDC's effort to engage the public was revitalized in mid-2008 and after the election of President Obama, who is an advocate of the public engagement process to create mechanisms for meaningful dialogue that will result in well informed and wise government policy.
There is reason to celebrate whenever government officials and vaccine stakeholders support more research into the biological mechanisms and biomarkers for vaccine injury and death. That being said, I have learned first hand that change in government policy can be painfully slow. And so, when another mother calls to tell me that her daughter has died after Gardasil vaccine or is lying crippled in bed unable to walk, my celebration of this vaccine stakeholder recommendation is tempered by the tears I shed with mothers, whose children are being injured by government recommended vaccines today.
Still, it is a hopeful sign that health officials in the new Administration are listening to the legitimate calls for more and better vaccine safety science and will work more effectively with citizens to prevent vaccine injuries and deaths now and in the future. As was discussed in Salt Lake City, the participatory democracy model with regard to government- sponsored research into vaccine-related immune and brain dysfunction, should include transparency and public participation in the design and oversight on conducting of that research.
On March 16, 2009 from 9 to 5 p.m. at the Hubert Humphrey Building, 200 Independence Ave. SW, Washington, D.C., the National Vaccine Advisory Committee will hold an open public meeting for citizens to discuss the government's draft vaccine safety research agenda.
To register to attend, contact Kirsten Vannice at: Kirsten.vannice@hhs.gov. To join the meeting via telephone or by webscast, go to http://www.hhs.gov/nvpo/nvac/PublicEngageme nt.html
February 2009 turned out to be a month when vaccine science was put on trial in the U.S. Court of Claims in Washington, D.C., in mainstream media and on the internet, in the British Medical Journal and in vaccine safety research initiatives by the U.S. Department of Health and Human Services. Despite concerted efforts by some to close the book on vaccine-related brain dysfunction that includes autism spectrum disorders, it is clear that the search for scientific truth will continue as it always must in science.
The month began with a Feb. 6 CBS-TV news report on new information released by NVIC on serious Gardasil risks, which was followed within 48 hours by a highly orchestrated and very well publicized transatlantic attack on MMR vaccine researcher Andrew Wakefield, M.D. in preparation for a Feb. 12 public announcement by the U.S. Court of Claims denying federal compensation to three children, who regressed into autism after MMR vaccination. The same day that three autistic children were denied federal compensation in the U.S., the British Medical Journal published a Cochrane Collaboration analysis revealing that influenza vaccine studies are more likely to be published in medical journals and rated highly if they are funded by pharmaceutical companies, even when the vaccine studies are of poor quality.
The month ended on a hopeful note with a joint statement finalized February 27 by a CDC- sponsored vaccine safety writing workgroup that asked the National Vaccine Advisory Committee (NVAC) to consider conducting more research into the vaccine schedule, whether some children are biologically at greater risk than others for suffering vaccine reactions and whether there are differences in immune and brain function between vaccinated vs. unvaccinated children. The proposal to investigate adding these kinds of studies to the national vaccie safety research agenda, if approved by the entire NVAC, would include identification of biological markers and biological differences, if any, in brain and immune system function between vaccinated and unvaccinated children.
In a questionable "class action" type Omnibus hearing process, whereby the U.S. Department of Justice allowed (encouraged?) some 5,000 cases of regressive autism after vaccination to be lumped together and argued by plaintiff's lawyers using two narrow biological mechanism hypotheses involving thimerosal and MMR vaccine, the first three Omnibus cases were rejected by three special masters employed by the U.S. Court of Claims. The Court relied heavily on epidemiological studies published in medical journals - the same medical journals which give preferential treatment to methodologically flawed studies funded by vaccine manufacturers.
In a distortion of the National Childhood Vaccine Injury Act that created the Vaccine Injury Compensation Program (VICP), the Court appears to have inappropriately assumed authority that Congress never gave them in 1986: to act as judge and jury on a global scientific question yet to be definitively answered by medical science. The special masters of the Court are neither qualified nor was the 1986 law intended to give them the power to determine the scientific validity of whether vaccines can ever cause autism or any other permanent injury. The special masters were supposed to be administrators and facilitators for providing no-fault, non adversarial federal vaccine injury compensation in lieu of a civil lawsuit against vaccine manufacturers and physicians. In fulfilling that responsibility, these administrators for the Court were supposed to "presume" causation in the absence of a more biologically plausible explanation for the child's injuries or death.
The tragic consequence of this and other politically motivated distortions of the 1986 law is that thousands of previously healthy children, who suffered brain injury and regressed into autism after vaccination, are now in danger of having their vaccine injury claims prejudicially judged and dismissed without being given their own day in "vaccine court." Most of these children certainly will never have their day in civil court in front of a jury of their peers.
Vaccine injury cases are each different due to biodiversity, individual extenuating circumstances, vaccines or combination of vaccines given, plus a number of biological mechanisms for vaccine injury and death - known and unknown - that can be argued in an individual case. This means that an individualized, not a group, approach to obtaining and awarding federal vaccine injury compensation is required. A case in point is the Feb. 20 release of a U.S. Court of Claims compensation award to a child who suffered brain inflammation (Acute Disseminated Encephalomyelitis) after MMR vaccination and was left with permanent brain dysfunction, including autism.
There have been other awards in the VICP for cases of DPT and DTaP vaccine induced brain inflammation/encephalopathy that caused permanent brain injury, including autism. A long acknowledged serious complication of both infectious disease and vaccination is acute brain inflammation that can cause chronic brain dysfunction manifested in many different ways. (See Vaccines, Autism & Chronic Inflammation: The New Epidemic)
So, despite the concerted efforts by some to misrepresent the legal and political significance of recent U.S. Court of Claims judgments in order to dismiss vaccine associated autism as having no scientific validity, vaccine safety advocates have pledged to continue calls for credible scientific investigation into vaccine related neuroimmune dysfunction. Andrew Wakefield is demonstrating the same resolve by taking action to clear his name from libelous and slanderous charges by an obsessed British newspaper reporter who is behaving more like a jilted suitor-turned stalker than a credible journalist. Needless to say, Dr. Wakefield and others will continue scientific research into vaccine associated brain and immune system dysfunction in a dedicated effort to add to the base of scientific knowledge about vaccination.
Finally, it is a hopeful sign that at the end of February a joint statement was signed by a diverse group of vaccine stakeholders who met in Salt Lake City Feb. 20-21, 2009 to discuss national vaccine safety research priorities. Assisted by expert facilitators from The Keystone Center, the CDC sponsored Vaccine Safety Writing Group included federal and state public health officials, pediatricians, infectious disease specialists, immunologists, vaccine developers, health policy analysts, child vaccine advocates and representatives from vaccine safety and autism groups including NVIC, SafeMinds and Autism Speaks.
The vaccine stakeholder group stated that the National Vaccine Advisory Committee (NVAC) should "charge an expert panel with evaluating study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. This draft charge is responsive to issues raised at community meetings in Alabama, Oregon and Indiana as well as the Interagency Autism Coordinating Committee request for collaboration with the National Vaccine Program Office."
The group further stated that :
"There is a strong desire to study the health impact of the immunization schedule, potentially through a 'vaccinated vs. unvaccinated study.' Outcomes to assess include biomarkers of immunity and metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities. The inclusion of autism as an outcome is desired."
The meeting of vaccine stakeholders was the latest in a series of government/citizen encounters that began in 2002 in a CDC-sponsored participatory democracy initiative called the Vaccine Policy Analysis Collaborative. Although the original vaccine stakeholder group dissolved in 2005, the CDC's effort to engage the public was revitalized in mid-2008 and after the election of President Obama, who is an advocate of the public engagement process to create mechanisms for meaningful dialogue that will result in well informed and wise government policy.
There is reason to celebrate whenever government officials and vaccine stakeholders support more research into the biological mechanisms and biomarkers for vaccine injury and death. That being said, I have learned first hand that change in government policy can be painfully slow. And so, when another mother calls to tell me that her daughter has died after Gardasil vaccine or is lying crippled in bed unable to walk, my celebration of this vaccine stakeholder recommendation is tempered by the tears I shed with mothers, whose children are being injured by government recommended vaccines today.
Still, it is a hopeful sign that health officials in the new Administration are listening to the legitimate calls for more and better vaccine safety science and will work more effectively with citizens to prevent vaccine injuries and deaths now and in the future. As was discussed in Salt Lake City, the participatory democracy model with regard to government- sponsored research into vaccine-related immune and brain dysfunction, should include transparency and public participation in the design and oversight on conducting of that research.
On March 16, 2009 from 9 to 5 p.m. at the Hubert Humphrey Building, 200 Independence Ave. SW, Washington, D.C., the National Vaccine Advisory Committee will hold an open public meeting for citizens to discuss the government's draft vaccine safety research agenda.
To register to attend, contact Kirsten Vannice at: Kirsten.vannice@hhs.gov. To join the meeting via telephone or by webscast, go to http://www.hhs.gov/nvpo/nvac/PublicEngageme nt.html
Vaccine Studies: Under the Influence of Pharma
by Barbara Loe Fisher
If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout. It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn't get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection. It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC's policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.
Today, a study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies conducted by Tom Jefferson, M.D., Ph.D. and his colleagues, they found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.
Click here to view the BMJ study:
Jefferson's analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety. The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D., who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade by both Pharma-funded special interest groups as well as public health officials maintaining close relationships with vaccine manufacturers.
Jefferson and his colleagues identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles. They also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.
Dr. Jefferson commented, "The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.
Earlier this week the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates. In 2006, Merck's Gardasil vaccine was fast tracked by the FDA at Merck's request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.
The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.
In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six. Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.
In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.
Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective - evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children - then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.
Government vaccine recommendations, U.S. Court of Claims vaccine injury compensation awards and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.
Kudos to the British Medical Journal for having the integrity to publish Jefferson's comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S..
BMJ
Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review
T Jefferson, coordinator, C Di Pietrantonj, statistician, M G Debalini, researcher, A Rivetti, researcher , V Demicheli, director of health, Piemonte region
Cochrane Vaccines Field, ASL(Azienda Sanitaria Locale) AL 20,15100 Alessandria, Italy
Correspondence to: T Jefferson jefferson.tom@gmail.com
Cite this as: BMJ 2009;338:b354 doi:10.1136/bmj.b354
ABSTRACT
Objective To explore the relation between study concordance, take home message, funding, and dissemination of comparative studies assessing the effects of influenza vaccines.
Design Systematic review without meta-analysis.
Data extraction Search of the Cochrane Library, PubMed, Embase, and the web, without language restriction, for any studies comparing the effects of influenza vaccines against placebo or no intervention. Abstraction and assessment of quality of methods were carried out.
Data synthesis We identified 259 primary studies (274 datasets). Higher quality studies were significantly more likely to show concordance between data presented and conclusions (odds ratio 16.35, 95% confidence interval 4.24 to 63.04) and less likely to favour effectiveness of vaccines (0.04, 0.02 to 0.09). Government funded studies were less likely to have conclusions favouring the vaccines (0.45, 0.26 to 0.90). A higher mean journal impact factor was associated with complete or partial industry funding compared with government or private funding and no funding (differences betweenmeans5.04). Study sizewas not associated with concordance, content of take home message, funding, and study quality. Higher citation index factor was associated with partial or complete industry funding. This was sensitive to the exclusion from the analysis of studies with undeclared funding.
Conclusion Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.
If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout. It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn't get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection. It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC's policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.
Today, a study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies conducted by Tom Jefferson, M.D., Ph.D. and his colleagues, they found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.
Click here to view the BMJ study:
Jefferson's analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety. The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D., who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade by both Pharma-funded special interest groups as well as public health officials maintaining close relationships with vaccine manufacturers.
Jefferson and his colleagues identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles. They also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.
Dr. Jefferson commented, "The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.
Earlier this week the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates. In 2006, Merck's Gardasil vaccine was fast tracked by the FDA at Merck's request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.
The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.
In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six. Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.
In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.
Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective - evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children - then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.
Government vaccine recommendations, U.S. Court of Claims vaccine injury compensation awards and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.
Kudos to the British Medical Journal for having the integrity to publish Jefferson's comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S..
BMJ
Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review
T Jefferson, coordinator, C Di Pietrantonj, statistician, M G Debalini, researcher, A Rivetti, researcher , V Demicheli, director of health, Piemonte region
Cochrane Vaccines Field, ASL(Azienda Sanitaria Locale) AL 20,15100 Alessandria, Italy
Correspondence to: T Jefferson jefferson.tom@gmail.com
Cite this as: BMJ 2009;338:b354 doi:10.1136/bmj.b354
ABSTRACT
Objective To explore the relation between study concordance, take home message, funding, and dissemination of comparative studies assessing the effects of influenza vaccines.
Design Systematic review without meta-analysis.
Data extraction Search of the Cochrane Library, PubMed, Embase, and the web, without language restriction, for any studies comparing the effects of influenza vaccines against placebo or no intervention. Abstraction and assessment of quality of methods were carried out.
Data synthesis We identified 259 primary studies (274 datasets). Higher quality studies were significantly more likely to show concordance between data presented and conclusions (odds ratio 16.35, 95% confidence interval 4.24 to 63.04) and less likely to favour effectiveness of vaccines (0.04, 0.02 to 0.09). Government funded studies were less likely to have conclusions favouring the vaccines (0.45, 0.26 to 0.90). A higher mean journal impact factor was associated with complete or partial industry funding compared with government or private funding and no funding (differences betweenmeans5.04). Study sizewas not associated with concordance, content of take home message, funding, and study quality. Higher citation index factor was associated with partial or complete industry funding. This was sensitive to the exclusion from the analysis of studies with undeclared funding.
Conclusion Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.
Gardasil Death & Brain Damage: A National Tragedy
by Barbara Loe Fisher
The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6, CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here)
Today, NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress to investigate the fast track licensure and universal use recommendation of Gardasil in 2006 and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System (VAERS) as a "coincidence" by federal health officials.
NVIC's latest Gardasil risk report comparing the number and severity of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination. If the deaths and serious injuries being reported after Gardasil were only a "coincidence," there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines if the vaccines were equally reactive and the number of doses were roughly the same.
Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds. Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated. Menatra is given as one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.
This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil - if every girl got three doses - were given to about five million girls. It is individuals - not doses of vaccine - who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.
What is sad is that the average junior high or high school student could do this VAERS analysis and come to the same conclusion. It does not take an M.D., Ph.D. or math genius to figure it out. In the hours before the CBS News report was broadcast, the best answer that Merck could come up with to address the differences between adverse events associated with Gardasil and Menactra was this:
"It's important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer. Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said "GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks." NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov."
No, it doesn't take a doctor, health official or "medical organization" to do the math. What it takes is caring about every life - whether that life represents a baby, toddler, child, teenager, young adult, adult or senior citizen - because every life is important and nobody deserves to be written off by a drug company or government agency as an expendable casualty of public health policy.
Gabrielle, the 15 year old gymnast, honor roll student and cheerleader from Wichita, Kansas, who talks about how her health has been destroyed by Gardasil vaccine in the CBS report and in the NVIC video press release, spends most of her time at home or at doctors' offices now. A few weeks ago, her school voted her Homecoming Princess. On Saturday, she tried to go to the Homecoming dance. As she was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she has been taking to try to control the seizures she developed after Gardasil vaccination caused her to develop kidney stones. She was rushed to the emergency room and hospitalized.
In the past 27 years, the stories of death and brain damage that have been reported to the National Vaccine Information Center have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.
Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials. That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.
Americans are losing trust in pharmaceutical companies making drugs and vaccines and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary. If those responsible for protecting our health are not going to step up to the plate and do their jobs, then it is up to the people to do it.
At www.NVIC.org you can sign the Investigate Gardasil Vaccine Risks Now! petition, read NVIC's new report on Gardasil risks, and check out our new website that makes it easier to navigate and find information to prevent vaccine injuries and deaths.
In 2009, I have a sense of déjà vu, as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980's to persistent reports that DPT vaccine was harming more children than originally assumed and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed. Assumption of safety is no substitute for proof of safety. And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.
In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said "Let them eat cake." It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France. In the 21st century, today's peasants don't have pitchforks - they have laptops, desktops, smartphones and the internet.
The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6, CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here)
Today, NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress to investigate the fast track licensure and universal use recommendation of Gardasil in 2006 and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System (VAERS) as a "coincidence" by federal health officials.
NVIC's latest Gardasil risk report comparing the number and severity of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination. If the deaths and serious injuries being reported after Gardasil were only a "coincidence," there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines if the vaccines were equally reactive and the number of doses were roughly the same.
Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds. Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated. Menatra is given as one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.
This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil - if every girl got three doses - were given to about five million girls. It is individuals - not doses of vaccine - who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.
What is sad is that the average junior high or high school student could do this VAERS analysis and come to the same conclusion. It does not take an M.D., Ph.D. or math genius to figure it out. In the hours before the CBS News report was broadcast, the best answer that Merck could come up with to address the differences between adverse events associated with Gardasil and Menactra was this:
"It's important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer. Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said "GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks." NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov."
No, it doesn't take a doctor, health official or "medical organization" to do the math. What it takes is caring about every life - whether that life represents a baby, toddler, child, teenager, young adult, adult or senior citizen - because every life is important and nobody deserves to be written off by a drug company or government agency as an expendable casualty of public health policy.
Gabrielle, the 15 year old gymnast, honor roll student and cheerleader from Wichita, Kansas, who talks about how her health has been destroyed by Gardasil vaccine in the CBS report and in the NVIC video press release, spends most of her time at home or at doctors' offices now. A few weeks ago, her school voted her Homecoming Princess. On Saturday, she tried to go to the Homecoming dance. As she was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she has been taking to try to control the seizures she developed after Gardasil vaccination caused her to develop kidney stones. She was rushed to the emergency room and hospitalized.
In the past 27 years, the stories of death and brain damage that have been reported to the National Vaccine Information Center have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.
Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials. That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.
Americans are losing trust in pharmaceutical companies making drugs and vaccines and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary. If those responsible for protecting our health are not going to step up to the plate and do their jobs, then it is up to the people to do it.
At www.NVIC.org you can sign the Investigate Gardasil Vaccine Risks Now! petition, read NVIC's new report on Gardasil risks, and check out our new website that makes it easier to navigate and find information to prevent vaccine injuries and deaths.
In 2009, I have a sense of déjà vu, as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980's to persistent reports that DPT vaccine was harming more children than originally assumed and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed. Assumption of safety is no substitute for proof of safety. And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.
In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said "Let them eat cake." It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France. In the 21st century, today's peasants don't have pitchforks - they have laptops, desktops, smartphones and the internet.
The Great Denial of Vaccine Risks & Freedom
A man of conscience: Will he end the Great Denial of vaccine risks?
By Barbara Loe Fisher
The Great Denial of vaccine risks for the past three decades by vaccine makers, pediatricians and government officials operating the mass vaccination system is the reason why more and more parents today question and mistrust vaccine science, policy and law. When Harris Coulter and I co-authored DPT: A Shot in the Dark in 1985 exposing flaws in the mass vaccination system that allowed the highly reactive DPT vaccine to stay on the market unimproved for more than 40 years, we never imagined then that those tragic flaws in the system would remain largely intact in 2009.
I knew then that the alliance between industry, organized medicine and government was powerful. But it is only after a quarter century of witnessing the Great Denial of vaccine risks, which has produced millions of vaccine damaged children flooding special education classrooms and doctors offices, that the magnitude of that unchecked power has been fully revealed.
Thomas Jefferson, co-author of the U.S Constitution, said in 1820: "We are not afraid to follow truth wherever it may lead, nor to tolerate any error so long as reason is left free to combat it." When those in power are so afraid of the truth that they abandon reason and are willing to tolerate all kinds of errors in order to hide the truth, people suffer.
Fear of the truth was clearly in play at a Jan. 14 meeting of the Federal Interagency Autism Advisory Committee (IACC) when the Committee took a convenient "re-vote" to nullify a previous vote to use a portion of congressionally appropriated funds in the Combating Autism Act of 2006 to investigate the long reported association between vaccination and autism. Whether the "re-vote" can be blamed on a turf war between federal agencies, a Committee member who defied direction given to her by her employer, Autism Speaks, or a desperate, last minute end-run by health officials to again delay the day when the truth about vaccine risks is known, it is the people who always lose in this high stakes game of denials and delays.
Thomas Jefferson had a lot to say about power, coercion and freedom. He said "Subject opinion to coercion: whom will you make your inquisitors? Fallible men; men governed by bad passions, by private as well as public reasons." Ask Rita Palma of New York what it means to be subjected to an inquisition about her religious beliefs by an arrogant and fallible man governed by passions and driven to harass and coerce her for private as well as public reasons. Click here and also click here to watch videos of an attorney, acting on behalf of the state of New York, as he puts Rita on the rack and browbeats her for her religious beliefs and faith in God when it comes to vaccinating her children.
Rita has been working with other parents in New York to support the addition of philosophical exemption to vaccination to New York vaccine laws to protect parents, who exercise religious exemptions, and doctors, who issue medical exemptions from harassment by state officials. A public Vaccine Education Roundtable was sponsored by New York Assemblymen Marc Alessi and Richard Gottfried on Dec. 15, 2008 at Stony Brook University to examine vaccine safety and informed consent issues.
Reason and faith, conscience and science, truth and freedom. Those who participate in the Great Denial of vaccine risks cannot tolerate an unbiased, methodologically sound scientific investigation into those risks. And they cannot tolerate the free exercise of religious belief and conscience by those, whose minds and bodies they must control in order to perpetuate the Great Denial.
In 1997, I was asked to present an argument for the moral right to conscientious belief exemption to vaccination to the National Vaccine Advisory Committee in Washington, D.C. After my 20 minute presentation, there was a several hour "discussion" where I was grilled by public health officials who alternately acknowledged the importance of the informed consent principle and called me "selfish," a "threat to the public health" and "uninformed."
The defining moment of that encounter, for me at least, came when I looked the physician architect of the CDC-led "No shots, No school" campaign in the eye and said "Whether or not I put my child's life on the line for you and your vaccines is between me and my God and not between me and you, Doctor." The way he gritted his teeth and glared at me while his face flushed bright red, spoke volumes about what the Great Denial is all about. It is about whether we, the citizens, are going to have the power to freely choose which pharmaceutical products or other medical interventions we are going to use or whether that power is going to be taken from us by doctors and public health officials.
Jacobsen v. Massachusetts is the U.S. Supreme Court decision which affirmed the constitutional right of the states to enact mandatory vaccination laws. Concerned about controlling smallpox, little did the justices at the turn of the 20th century imagine that federal officials would someday recommend 69 doses of 16 vaccines for children from 12 hours of age through age 18 or that New Jersey would mandate more than three dozen doses of 13 vaccines for children to attend school. In an insightful review of that historic 1905 Supreme Court decision, the Harvard Law Review recently examined the application of Jacobsen v. Massachusetts to vaccine laws in the 21st century.
If one citizen or group of citizens in America are allowed to force fellow citizens to risk injury or death without their voluntary, informed consent, then are Americans free in any sense of the word? When forced risk-taking involves mandated use of pharmaceutical products protected from liability in the Judicial system, which the authors of the Constitution created as a check and balance on the Executive and Legislative branches of government, then people can be easily exploited for power and profit. Unless vaccines and other pharmaceutical products are subject to the law of supply and demand so citizens can freely choose those which are necessary, safe and effective and reject those which are not, the people become nothing more than enslaved consumers of potentially dangerous products marketed by companies with no economic or legal incentive to improve those products.
And if the state can tag, track down and force individuals against their will to be injected with biologicals of unknown toxicity today, then there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.
As the 44th President of the United States is sworn in today in our nation's Capitol, we can only pray that he will have the intelligence, compassion and conscience to make sure that his Administration is not afraid to find out the truth about vaccine risks. With one child in six now developmentally delayed in America and no answers from government health officials as to how they got that way, our nation's future may depend on it.
The National Vaccine Information Center is prepared to stand with other parent groups representing families with vaccine injured children to call for an end to the Great Denial by those responsible for ensuring our children's health and safety.
Let freedom ring: No forced vaccination. Not in America.
2009: The Vaccine Freedom Tipping Point
by Barbara Loe Fisher
Last night the nighttime medical soap opera, "Private Practice," on ABC-TV demonized parents of children with MMR-vaccine related autism for refusing to vaccinate normal siblings while glorifying doctors forcibly vaccinating children without parental consent. The segment entitled "Contamination" left the viewer with the impression that every child who gets measles will die and that MMR vaccine poses no risks whatsoever to any child. It was a cheap shot at parents with vaccine injured children trying to protect their healthy children from vaccine injury and yet another wake-up call for Americans, who understand the importance of voluntary, informed consent to taking any pharmaceutical product or undergoing any medical procedure that can injure and kill.
As 2008 ended and the New Year began, evidence that the "Tipping Point" in the 27-year old vaccine safety and informed consent movement has arrived is becoming more apparent. There is the escalating rhetoric and hyperbole being spewed by the evangelistic pediatrician from Children's Hospital of Philadelphia, who called for doctors to be burned at the stake for the heresy of individualizing CDC and AAP vaccine use guidelines. In a brilliant letter to Pediatrics, it was a parent of a vaccine injured child, neurologist Jon Poling, M.D., who pointed out why sophomoric errors in logic and misunderstanding of the scientific method invalidated the claims of Paul Offit. Soon Dr. Poling was joined by others speaking out in defense of pediatricians like Bob Sears, M.D., who are wisely advocating that doctors and parents engage in shared vaccine decision-making for children.
Then there was the stern reminder to parents from militant New Jersey health officials that babies must get flu shots by January 2009 or face being kicked out of daycare and pre-school. Parents living in the state with the most vaccine mandates (41 doses of 13 vaccines), especially those with children already suffering with health problems, are trying to protect their children from further damage but have no recourse because New Jersey state law only allows restrictive medical and religious exemptions. Vaccine educated parents are writing letters to legislators urging them to pass a conscientious belief exemption to vaccination.
After a Dec. 14 legislative roundtable discussion at Stony Brook University with proponents for and against addition of a philosophical exemption to New York vaccine laws, vaccine educated parents are urging that letters be written to legislators (New York Assembly at http://assembly.stat e.ny.us/ and New York Senate at http://www.senate.state.ny.us/senatehom epage.nsf/senators?OpenForm ) and also to New York Governor David Paterson, Executive Chamber, State Capitol, Albany, NY 12224 in support of the exemption.
Merck rang in the New Year trying to pump up sales of the reactive Gardasil vaccine by asking the FDA to open up the young boy market, while Prevnar-maker Wyeth is making a bid to become the world's most profitable vaccine manufacturer. The Jan. 1 voluntary moratorium by drug companies on giving doctors free pens and trinkets is a token drop in the bucket compared to the big bucks Big Pharma will spend in 2009 to keep doctors convincing Americans that the only way they can stay healthy is to consume more and more drugs and vaccines.
But then came a breath of fresh air this week when the formidable M.I.N.D. Institute at UC-Davis published an epidemiological study confirming that the autism epidemic that has emerged during the past three decades is not due to genetics or "better counting" but is likely caused by environmental co-factors.
2009 is off to a contentious, challenging and promising start. Like all social movements that advocate reform of institutions stubbornly resistant to change, the way is not easy and change does not come quickly or without sacrifice. The three-decade U.S. vaccine safety and informed consent movement is approaching its final and most important stage: the fight for freedom of choice. As several hundred vaccines are being developed and tested in several thousand clinical trials around the world and drug companies are jockeying for market-share positions, doctors are trying harder to convince Americans that 69 doses of 16 vaccines given to children between birth and age 18 will keep America healthy.
The argument that more vaccination will equal better health is an argument that is getting harder to make as one in two Americans suffers from chronic disease and America plummets to 39th in infant mortality while 25 percent of all children are suffering with learning disabilities, ADHD, severe allergies, autism, asthma, diabetes, inflammatory bowel disorder, rheumatoid arthritis and other chronic immune and brain disorders. The question that doctors and public health officials fear most is:
WHY IS THE MOST HIGHLY VACCINATED CHILD POPULATION IN THE WORLD SO SICK AND DISABLED?
Until that question is answered by doctors and public health officials, there aren't enough daytime or evening soap operas, bogus news reports and poorly conducted studies claiming that vaccines are totally safe, or threats by vaccine patent holders and doctors shouting "coincidence" every time another child regresses into chronic poor health after vaccination to keep the tipping point from tipping.
Happy New Year!
"Sears' book, published in October 2007 as part of the Sears Parenting Library, has already sold more than40,000 copies and has moved into the top 100 on the Amazon.com bestseller list. The popularity of Sears' book centers in part on 2 schedules, called alternative and selective, that offer parents a way to avoid giving their children several vaccines at one time. Sears' book is unique. Unlike typical antivaccine books, he offers a middle ground, allowing parents to act on their fears without completely abandoning vaccines. Unfortunately, Sears sounds many antivaccine messages....At the heart of the problem with Sears' schedules is the fact that, at the very least, they will increase the time during which children are susceptible to vaccine-preventable diseases. If more parents insist on Sears' vaccine schedules, then fewer children will be protected, with the inevitable consequence of continued or worsening outbreaks of vaccine-preventable diseases. In an effort to protect children from harm, Sears' book will likely put more in harm's way." - Paul Offit, Pediatrics (December 29, 2008) http://pediatrics.aappublications.org/cg i/content/full/123/1/e164
"In their assault on Dr. Sears, Offit and Moser confuse scientific methodology. Even more dangerous than not having an understanding of science, is the presumption that one does "grasp the scientific method." Actually, in designing an epidemiological study, one must have a good estimate of the effect size, in order to determine the power of a study. Offit misuses the statistical term 'power' to suggest that this allows one to "reject or not to reject the null hypothesis." This is incorrect.....As physicians we took an oath to 'first do no harm' to our individual patients. Dr. Sears offers a pro-vaccine individualized approach to childhood immunization that acknowledges the risks, benefits, and uncertainties of this medical intervention. Dr. Sears should be applauded for his efforts to provide safe vaccination alternatives to his patients, given the void of randomized controlled trials to support continued growth of the current CDC/AAP schedule. Rather than personal attacks, let's turn to science to provide the answers. The enormous public benefit of vaccination cannot be used to stifle open discourse on critical vaccine safety issues. One size does not fit all." - Jon Poling, Pediatrics (January 2, 2009)
http://pediatrics.aappublications.or g/cgi/eletters/123/1/e164#39891
"The state's new law requiring young children attending licensed pre-school and child care centers to get flu vaccinations will be tested this week when thousands of children return to classrooms and playrooms after the long holiday break. New Jersey, the first state in the nation to require flu shots for young schoolchildren, set a Dec. 31 deadline for parents to obtain flu vaccinations for their children. It was part of a new policy requiring a total of four additional immunizations for schoolchildren over the objections of some parents who worry about possible risks from vaccinations. The requirement applies to children between 6 months and 5 years who are attending licensed day care and preschool programs." - Derrick Henry, New York Times (January 4, 2009) http://www.nytimes.com/2009/01/ 04/nyregion/new-jersey/04flunj.html? _r=1&ref=education
"Merck filed last month for approval from the Food and Drug Administration for the use of its drug Gardasil by males between the ages 9 to 26, CNBC has confirmed. Since 2006, Gardasil has been approved as a means of preventing cervical and other types of cancer in girls and women. Males carry and transmit the sexually-transmitted virus HPV, which is the leading cause of cervical cancer. Gardasil, a vaccine against HPV, has been a blockbuster product for Merck , but sales growth for the drug has slowed. Approval for boys and older women could help reinvigorate that...." - Mike Huckman, CNBC-TV (January 5, 2009) http://www.cnbc.com/id/28506419/
"Wyeth may become one of the world's biggest vaccine makers with the acquisition of Crucell NV, a Dutch developer of medicines against AIDS, rabies, and Ebola. The drugmaker is in talks to buy Crucell, based in Leiden, Netherlands, for $1.35 billion, according to a person familiar with the deal....Wyeth Chief Executive Officer Bernard Poussot has focused the company's research on vaccines, a dependable source of sales for drugmakers because they don't lose patent protection and are often purchased by governments. Poussot turned Wyeth's pneumonia vaccine Prevnar into its second best-selling product with $2.4 billion in 2007 revenue...." - Shannon Pettypiece, Bloomberg News January 8, 2009 http://www.bloomberg.com/apps/news? pid=20601087&sid=as4rY9TI49Yo&refer=worldwide#
"Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded goodies - Viagra pens, Zoloft soap dispensers, Lipitor mugs - that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs. No longer will Merck furnish doctors with purplish adhesive bandages advertising Gardasil, a vaccine against the human papillomavirus....But some critics said the code did not go far enough to address the influence of drug marketing on the practice of medicine. The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations....The industry code also permits drug makers to pay doctors as consultants "based on fair market value" - which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year. "We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers," said Allan Coukell, the director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine. "Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good." - Natasha Singer, New York Times (December 31, 2008) http://www.nytimes.com/2008/ 12/31/business/31drug.html? partner=rss&emc=rss
"It is time to focus on environmental causes for the rapid rise in autism, a leading researcher said Thursday, after her study concluded that such factors as earlier diagnosis and families moving to California cannot fully explain a dramatic seven- to eightfold increase in the state since the early 1990s. "With no evidence of a leveling off, the possibility of a true increase in incidence deserves serious consideration," states the study, published in the January issue of the journal Epidemiology.... Rick Rollens, the father of an autistic child and co-founder of the M.I.N.D. Institute, agreed. "This is a definitive study that should once and for all put the proverbial nail in the coffin of those who have been denying the existence of an autism epidemic," he said. "The sooner that people recognize the significance of this crisis, the sooner we'll be on our way in trying to address the needs of the children and families," Rollens said." - Sandy Kleffman, Contra Costa Times (January 9, 2009) http://www.contracostatimes.com/news/ci _11411611?source=rss
Last night the nighttime medical soap opera, "Private Practice," on ABC-TV demonized parents of children with MMR-vaccine related autism for refusing to vaccinate normal siblings while glorifying doctors forcibly vaccinating children without parental consent. The segment entitled "Contamination" left the viewer with the impression that every child who gets measles will die and that MMR vaccine poses no risks whatsoever to any child. It was a cheap shot at parents with vaccine injured children trying to protect their healthy children from vaccine injury and yet another wake-up call for Americans, who understand the importance of voluntary, informed consent to taking any pharmaceutical product or undergoing any medical procedure that can injure and kill.
As 2008 ended and the New Year began, evidence that the "Tipping Point" in the 27-year old vaccine safety and informed consent movement has arrived is becoming more apparent. There is the escalating rhetoric and hyperbole being spewed by the evangelistic pediatrician from Children's Hospital of Philadelphia, who called for doctors to be burned at the stake for the heresy of individualizing CDC and AAP vaccine use guidelines. In a brilliant letter to Pediatrics, it was a parent of a vaccine injured child, neurologist Jon Poling, M.D., who pointed out why sophomoric errors in logic and misunderstanding of the scientific method invalidated the claims of Paul Offit. Soon Dr. Poling was joined by others speaking out in defense of pediatricians like Bob Sears, M.D., who are wisely advocating that doctors and parents engage in shared vaccine decision-making for children.
Then there was the stern reminder to parents from militant New Jersey health officials that babies must get flu shots by January 2009 or face being kicked out of daycare and pre-school. Parents living in the state with the most vaccine mandates (41 doses of 13 vaccines), especially those with children already suffering with health problems, are trying to protect their children from further damage but have no recourse because New Jersey state law only allows restrictive medical and religious exemptions. Vaccine educated parents are writing letters to legislators urging them to pass a conscientious belief exemption to vaccination.
After a Dec. 14 legislative roundtable discussion at Stony Brook University with proponents for and against addition of a philosophical exemption to New York vaccine laws, vaccine educated parents are urging that letters be written to legislators (New York Assembly at http://assembly.stat e.ny.us/ and New York Senate at http://www.senate.state.ny.us/senatehom epage.nsf/senators?OpenForm ) and also to New York Governor David Paterson, Executive Chamber, State Capitol, Albany, NY 12224 in support of the exemption.
Merck rang in the New Year trying to pump up sales of the reactive Gardasil vaccine by asking the FDA to open up the young boy market, while Prevnar-maker Wyeth is making a bid to become the world's most profitable vaccine manufacturer. The Jan. 1 voluntary moratorium by drug companies on giving doctors free pens and trinkets is a token drop in the bucket compared to the big bucks Big Pharma will spend in 2009 to keep doctors convincing Americans that the only way they can stay healthy is to consume more and more drugs and vaccines.
But then came a breath of fresh air this week when the formidable M.I.N.D. Institute at UC-Davis published an epidemiological study confirming that the autism epidemic that has emerged during the past three decades is not due to genetics or "better counting" but is likely caused by environmental co-factors.
2009 is off to a contentious, challenging and promising start. Like all social movements that advocate reform of institutions stubbornly resistant to change, the way is not easy and change does not come quickly or without sacrifice. The three-decade U.S. vaccine safety and informed consent movement is approaching its final and most important stage: the fight for freedom of choice. As several hundred vaccines are being developed and tested in several thousand clinical trials around the world and drug companies are jockeying for market-share positions, doctors are trying harder to convince Americans that 69 doses of 16 vaccines given to children between birth and age 18 will keep America healthy.
The argument that more vaccination will equal better health is an argument that is getting harder to make as one in two Americans suffers from chronic disease and America plummets to 39th in infant mortality while 25 percent of all children are suffering with learning disabilities, ADHD, severe allergies, autism, asthma, diabetes, inflammatory bowel disorder, rheumatoid arthritis and other chronic immune and brain disorders. The question that doctors and public health officials fear most is:
WHY IS THE MOST HIGHLY VACCINATED CHILD POPULATION IN THE WORLD SO SICK AND DISABLED?
Until that question is answered by doctors and public health officials, there aren't enough daytime or evening soap operas, bogus news reports and poorly conducted studies claiming that vaccines are totally safe, or threats by vaccine patent holders and doctors shouting "coincidence" every time another child regresses into chronic poor health after vaccination to keep the tipping point from tipping.
Happy New Year!
"Sears' book, published in October 2007 as part of the Sears Parenting Library, has already sold more than40,000 copies and has moved into the top 100 on the Amazon.com bestseller list. The popularity of Sears' book centers in part on 2 schedules, called alternative and selective, that offer parents a way to avoid giving their children several vaccines at one time. Sears' book is unique. Unlike typical antivaccine books, he offers a middle ground, allowing parents to act on their fears without completely abandoning vaccines. Unfortunately, Sears sounds many antivaccine messages....At the heart of the problem with Sears' schedules is the fact that, at the very least, they will increase the time during which children are susceptible to vaccine-preventable diseases. If more parents insist on Sears' vaccine schedules, then fewer children will be protected, with the inevitable consequence of continued or worsening outbreaks of vaccine-preventable diseases. In an effort to protect children from harm, Sears' book will likely put more in harm's way." - Paul Offit, Pediatrics (December 29, 2008) http://pediatrics.aappublications.org/cg i/content/full/123/1/e164
"In their assault on Dr. Sears, Offit and Moser confuse scientific methodology. Even more dangerous than not having an understanding of science, is the presumption that one does "grasp the scientific method." Actually, in designing an epidemiological study, one must have a good estimate of the effect size, in order to determine the power of a study. Offit misuses the statistical term 'power' to suggest that this allows one to "reject or not to reject the null hypothesis." This is incorrect.....As physicians we took an oath to 'first do no harm' to our individual patients. Dr. Sears offers a pro-vaccine individualized approach to childhood immunization that acknowledges the risks, benefits, and uncertainties of this medical intervention. Dr. Sears should be applauded for his efforts to provide safe vaccination alternatives to his patients, given the void of randomized controlled trials to support continued growth of the current CDC/AAP schedule. Rather than personal attacks, let's turn to science to provide the answers. The enormous public benefit of vaccination cannot be used to stifle open discourse on critical vaccine safety issues. One size does not fit all." - Jon Poling, Pediatrics (January 2, 2009)
http://pediatrics.aappublications.or g/cgi/eletters/123/1/e164#39891
"The state's new law requiring young children attending licensed pre-school and child care centers to get flu vaccinations will be tested this week when thousands of children return to classrooms and playrooms after the long holiday break. New Jersey, the first state in the nation to require flu shots for young schoolchildren, set a Dec. 31 deadline for parents to obtain flu vaccinations for their children. It was part of a new policy requiring a total of four additional immunizations for schoolchildren over the objections of some parents who worry about possible risks from vaccinations. The requirement applies to children between 6 months and 5 years who are attending licensed day care and preschool programs." - Derrick Henry, New York Times (January 4, 2009) http://www.nytimes.com/2009/01/ 04/nyregion/new-jersey/04flunj.html? _r=1&ref=education
"Merck filed last month for approval from the Food and Drug Administration for the use of its drug Gardasil by males between the ages 9 to 26, CNBC has confirmed. Since 2006, Gardasil has been approved as a means of preventing cervical and other types of cancer in girls and women. Males carry and transmit the sexually-transmitted virus HPV, which is the leading cause of cervical cancer. Gardasil, a vaccine against HPV, has been a blockbuster product for Merck , but sales growth for the drug has slowed. Approval for boys and older women could help reinvigorate that...." - Mike Huckman, CNBC-TV (January 5, 2009) http://www.cnbc.com/id/28506419/
"Wyeth may become one of the world's biggest vaccine makers with the acquisition of Crucell NV, a Dutch developer of medicines against AIDS, rabies, and Ebola. The drugmaker is in talks to buy Crucell, based in Leiden, Netherlands, for $1.35 billion, according to a person familiar with the deal....Wyeth Chief Executive Officer Bernard Poussot has focused the company's research on vaccines, a dependable source of sales for drugmakers because they don't lose patent protection and are often purchased by governments. Poussot turned Wyeth's pneumonia vaccine Prevnar into its second best-selling product with $2.4 billion in 2007 revenue...." - Shannon Pettypiece, Bloomberg News January 8, 2009 http://www.bloomberg.com/apps/news? pid=20601087&sid=as4rY9TI49Yo&refer=worldwide#
"Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded goodies - Viagra pens, Zoloft soap dispensers, Lipitor mugs - that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs. No longer will Merck furnish doctors with purplish adhesive bandages advertising Gardasil, a vaccine against the human papillomavirus....But some critics said the code did not go far enough to address the influence of drug marketing on the practice of medicine. The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations....The industry code also permits drug makers to pay doctors as consultants "based on fair market value" - which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year. "We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers," said Allan Coukell, the director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine. "Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good." - Natasha Singer, New York Times (December 31, 2008) http://www.nytimes.com/2008/ 12/31/business/31drug.html? partner=rss&emc=rss
"It is time to focus on environmental causes for the rapid rise in autism, a leading researcher said Thursday, after her study concluded that such factors as earlier diagnosis and families moving to California cannot fully explain a dramatic seven- to eightfold increase in the state since the early 1990s. "With no evidence of a leveling off, the possibility of a true increase in incidence deserves serious consideration," states the study, published in the January issue of the journal Epidemiology.... Rick Rollens, the father of an autistic child and co-founder of the M.I.N.D. Institute, agreed. "This is a definitive study that should once and for all put the proverbial nail in the coffin of those who have been denying the existence of an autism epidemic," he said. "The sooner that people recognize the significance of this crisis, the sooner we'll be on our way in trying to address the needs of the children and families," Rollens said." - Sandy Kleffman, Contra Costa Times (January 9, 2009) http://www.contracostatimes.com/news/ci _11411611?source=rss
New Yorker's Stand Up for Vaccine Exemptions
Photo courtesy Christine Zichittella-Heeren In the harbor of New York City stands the Statue of Liberty, a symbol of freedom that has welcomed millions of immigrants for 112 years, half of the time that the United States of America has been a nation. And on the base of the statue is an inscription that says in part ".....Give me your tired, your poor, your huddled masses yearning to breathe free...."
I remembered that phrase when we were driving from Washington, D.C. to New York City and our van got caught up in the Sunday afternoon Manhattan traffic that led us past the Empire State Building on our way to Long Island. Freedom was very much on my mind as we headed for Stony Brook University to participate in the December 15 Vaccine Education Roundtable sponsored by New York state Assemblymen Marc Alessi (D-1st Assembly District) and Richard Gottfried (D-75th Assembly District), who is Chair of the House Health Committee.
Americans have always cherished the freedom to breathe free; to speak, write and dissent without fear of retribution; to believe in God and worship freely without being persecuted; to vote for whom we want to represent us in government and know our vote counts; to follow our conscience and stand up for what is right. Although America is only 222 years old, which is very young compared to other countries that have existed for several thousands of years, during our short history there is no other nation that has defined and defended the freedom of citizens to live in a society based on the principle of equal rights and consent of the governed any better than the United States of America.
These are troubled times for parents in New York and New Jersey and other states. Every day parents are facing more hostility from pediatricians throwing them out of doctor's offices for questioning vaccine safety and are being harassed by government officials determined to force their children to get dozens of doses of state mandated vaccines without voluntary, informed consent. New York currently mandates more than two dozen doses of 11 vaccines for school attendance while New Jersey leads the nation with nearly three dozen doses of 13 vaccines, including annual influenza shots.
Religious exemptions are being pulled by state officials after they throw parents into rooms and grill them for hours about the sincerity of their religious beliefs. Last year in Maryland, state officials threatened several thousand parents with jail time and stiff fines for failing to show proof their children had gotten hepatitis B and chickenpox vaccinations.
It is in this climate of fear and crisis of trust between parents, who want a more equal role in making vaccination decisions for their children, and pediatricians and public health officials, who are determined to strengthen their power to tell parents what to do, that Assemblymen Alessi assembled a panel representing both sides to discuss whether or not a philosophical exemption to vaccination should be added to New York's vaccine laws. Currently New York only provides for a medical and religious exemption, even as 18 other states allow a personal, philosophical or conscientious belief exemption to vaccination.
After the Roundtable, Assemblyman Gottfried expressed strong support for First Amendment rights and told the audience of parents, doctors and legislative staff that he is sponsoring two bills to clarify rights defined under existing religious and medical exemptions so they cannot be violated by state officials. After the Roundtable concluded, he said "Important issues were raised. I look forward to seeing additional data from all sides, especially about the impact of the personal objection laws in other states. I will be reintroducing my bills to strengthen the religious and medical exemptions in the 2009 session. I urge parents to contact their local assembly members and state senators to urge them to co-sponsor."
Assemblyman Alessi commented that "The discussion framed the fact that there is still a large debate on the issue. And although some people in the medical community are adamant that this debate is over, it has only just begun. The amount of conflicting evidence parents are presented with regarding the effects of certain vaccines is staggering. This forum opened the lines of communication between experts in the debate and provided concerned parents with the most recent information on the safety of vaccines. As a parent, I know how difficult it is to make the right decisions regarding our children's health, but if we are to make good decisions, we need to be well informed and continue to have discussions like this roundtable."
At the beginning of the Roundtable, I framed the vaccine safety and informed consent debate and outlined how the informed consent principle relates to philosophical/conscientious belief exemption. I reviewed the general health ranking of New York (25th) compared to the 18 states which have philosophical exemptions (six of the top 10 ranked states have philosophical exemption) and noted that the U.S. uses more vaccines than any nation in the world but ranks 39th in infant mortality. Click here to read my entire presentation with live links to references (see text below).
Other panelists supporting philosophical exemption to vaccination included New York pediatrician Lawrence Palevsky, M.D. , who called for an authentic dialogue that "moves past what appears to a growing number of citizens to be a one-sided, paternalistic, and patronizing set of policies and language with an unwillingness to engage in a real discussion about the science of vaccines." He challenged many of the myths and misconceptions about the safety and effectiveness of vaccine policies.
New York's John Gilmore, executive director of Autism United, who has a vaccine injured son with autism and said "without trust, the proponents of forced vaccination have nothing but authority and authority is an unacceptable basis for any public policy in a democratic society." He pointed out operational flaws and conflicts of interest in vaccine safety regulation and policymaking. Louise Kuo Habakus, of the New Jersey Coalition for Vaccination Choice, who has two young sons recovering from vaccine injuries, presented slides summarizing vaccine risks and questioning whether vaccines can be credited with major infectious disease morbidity and mortality decreases in the 20th century. She recounted her impression of the day's events at http://rs6.net/tn.jsp?e=001dnwJjVVfQ9xgx6_wRS7lh7TxSNcnzFHoSfo95V0kXFw2U7DNhHIPfPmKAN3vPWmpywnIXqQY2UisLZ82JI5lBE3WrGzSK1ASjTXaAuzkYzzHsTxyufU8EA==. (In related events, New Jersey parents held several open houses this week to educate New Jersey legislators about the need to support pending conscientious belief exemption legislation in that state.)
Panelists defending current vaccine policies and opposing philosophical exemptions included New York pediatricians Paul Lee, M.D. , who agreed vaccine safety should be a high priority but disagreed that the amount of mercury and aluminum in vaccines posed a health risk; and longtime vaccine policymaker and American Academy of Pediatrics spokesperson Louis Z. Cooper, M.D. , who agreed trust between pediatricians and parents needs to be strengthened but defended the safety of existing vaccine policies; and Debra Blog, M.D. , medical director of the Immunization Program, New York State Department of Health, who showed slides of children with infectious diseases and strongly opposed adding philosophical exemption to New York state vaccine laws.
Following panelist presentations there was a spirited debate that lasted for more than two hours as panelists argued and defended their positions. NVIC's videographer, Chris Fisher, will be making a video of the day's events available on NVIC's website.
By the end of the day, I thought about how long parents of vaccine injured children have been asking pediatricians to become partners with them in preventing vaccine injuries and deaths. After nearly three decades, parents and doctors inside and outside of government could not be further apart. The failure of pediatricians and public health officials to take seriously the many cases of regression into poor health after vaccination has become the Number One public health problem in the U.S. today.
There will be no resolution until every state has embraced the informed consent ethic and adopted conscientious or philosophical exemption to vaccination in state vaccine laws. At that point, Americans will be free to vote with their feet and the vaccines the public considers to be necessary, safe and effective will be used and those they do not consider to be necessary, safe and effective will be driven off the market. And then, a real time comparison of the long term health of highly vaccinated, less vaccinated and unvaccinated citizens will tell us a lot about the safety and effectiveness of vaccine policies in the last half of the 20th and first half of the 21st centuries.
Statement of Barbara Loe Fisher
Co-founder & President, National Vaccine Information Center
December 15, 2008
at New York Stony Brook UniversityVaccine Education Roundtable
Assemblyman Alessi and NY State Legislators:
Thank you for holding this Vaccine Education Roundtable to discuss issues which impact on Assembly Bill 5468 to insert philosophical exemption in New York vaccine laws. I appreciate the invitation to be part of this panel on behalf of New York members of the National Vaccine Information Center, non-profit organization founded in 1982 to prevent vaccine injuries and deaths through public education and defend the informed consent ethic.
Vaccination is a medical intervention performed on a healthy person which carries an inherent risk of injury or death. The risk of harm can be greater for some than others and there is no guarantee that vaccination will, in fact, confer immunity. With very few predictors having been identified by medical science to give advance warning that harm or failure to confer immunity will occur, vaccination is a medical procedure that could reasonably be termed as experimental each time it is performed on a healthy individual.
Further, the FDA, CDC and vaccine makers openly state that often the numbers of human subjects used in pre-licensing studies are too small to detect all adverse events caused by a new vaccine. This makes government recommended use of newly licensed vaccines by millions of children a de facto uncontrolled national scientific experiment. In this regard, the ethical principle of informed consent to vaccination attains even greater significance.
Informed consent means that a patient or guardian has the right to be fully informed about the benefits and risks of a medical procedure and be allowed to make an informed, voluntary decision about whether or not to take the risk. Informed consent is an important check and balance for the relationship between physicians and patients that encourages physicians to obey the Hippocratic oath to "first, do no harm."
The affirmation of the informed consent ethic in the practice of modern medicine is rooted in a rejection of the traditional paternalistic medical model, which places the patient or guardian in an unequal, powerless position with a physician and facilitates uninformed, involuntary risk taking. The human right for individuals to exercise informed consent to participating in scientific experiments was officially acknowledged by the judges of the Nuremberg Tribunal after World War II. Their ringing endorsement of individual inviolability and the right to self determination when taking medical risks has became an internationally accepted moral guidepost for the ethical practice of modern medicine. The first principle of the Nuremberg Code begins with:
"The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision."
In America, the closest we come to upholding the informed consent principle with regard to vaccination is in the 18 states which allow personal, philosophical or conscientious belief exemption to vaccination. In the 2008 edition of America's Health Rankings, Vermont is ranked the number one healthiest state. Vermont allows philosophical exemption to vaccination. In fact, out of the top ten ranked healthiest states, six of them allow philosophical exemption (Vermont, Minnesota, Utah, Idaho, Maine, Washington).
New York ranks 25th in health behind the nation's most populous state, California. The state of California has twice as many residents as New York, as well as more foreign born residents and those who speak English as a second language. However, in almost all other demographics,
California is nearly identical to New York in ethnic diversity; numbers of children under age 18; median household income and persons living below poverty.
California allows philosophical exemption to vaccination.
What is interesting is that in the top 10 healthiest states, four had among the lowest vaccination rates for children ages 19 to 35 months: Utah (37th) , Idaho (45th), Maine (40th) and Washington (48th). California which is ahead of New York in overall health ranking, is 31st in vaccination coverage of 19 to 35 month olds while New York is number 9. The healthiest state, Vermont, is 29th in vaccination coverage.
In fact, health is not primarily measured by high vaccination rates or an absence of infectious disease. High vaccination rates are not the most important measure of the overall health of citizens. The 18 states allowing philosophical exemption to vaccination have not compromised individual or public health when compared to other states.
This past September, the CDC announced that national childhood vaccination rates are at near record levels, with at least 90 percent of young children receiving all but one CDC recommended vaccine. Less than 1 percent of children aged 19 to 35 months remain completely unvaccinated.
Today, the U.S. government recommends the use of more vaccines than any other country in the world: 69 doses of 16 vaccines for girls; 66 doses of 15 vaccines for boys given between the day of birth and age 18. That is triple the numbers of vaccinations recommended by public health officials and physician organizations a quarter century ago, when 23 doses of seven vaccines (DPT, MMR, OPV) were routinely given.
But in comparison to other nations, the overall health of Americans has not improved since 2004 and there are 27 countries that exceed the US in healthy life expectancy while the U.S. ranks 39th in infant mortality.
Today, 1 in every 143 babies born in America dies; 1 child in 450 becomes diabetic; 1 in 150 develops autism;1 in 9 suffers with asthma; and 1 in every 6 child is learning disabled.
The chronic disease and disability epidemic that has developed in the last quarter century is killing and injuring more children than any infectious disease epidemic in the history of our nation, including smallpox and polio. The social, economic, and human costs are enormous: nearly two billion dollars has been paid to vaccine victims by the federal government in the Vaccine Injury Compensation Program while three-quarters of the more than $2 trillion dollar annual price tag for health care is spent to care for the chronically ill and disabled.
The big question vaccine educated parents are asking is: why are so many of the most highly vaccinated children in the world so sick, suffering with all kinds of chronic brain and immune system dysfunction? Why are babies born in the richest country in the world dying more often than babies born in poorer countries, who do not get vaccinated at all or who get far fewer vaccines?
It is a question that has not been answered by any scientific study conducted to date because there has never been a large, prospective study comparing the long term health of highly vaccinated children to unvaccinated children. In the absence of definitive answers, the right to freely exercise medical, religious and philosophical exemption to vaccination is a human right that may well determine the biological integrity of this and future generations in America.
Because vaccines are pharmaceutical products that carry significant risks greater for some than others; because doctors and public health officials are not infallible; because what is considered scientific truth today can be proven false tomorrow; because philosophical exemption to vaccination does not negatively impact on the health of individuals or states; and because informed consent to medical risk taking is a human right, the National Vaccine Information Center urges legislators to affirm the freedom of all New Yorkers to make informed, voluntary vaccination decisions for themselves and their children by supporting philosophical exemption to vaccination.
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