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.
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.
Gardasil Deaths, Injuries & Money
by Barbara Loe Fisher
At the same time that more Gardasil injuries and deaths are being reported every day, those promoting mass use of Gardasil are busy denying the significance of vaccine reactions while Merck is making plans to increase its market share by asking young boys to roll up their sleeves as well.
The discussion in states about whether or not Gardasil should be mandated is still taking place even though all but two state legislatures (Virginia and D.C.) rejected mandates in 2007. It makes it easier for pro- forced vaccination proponents to keep proposed Gardasil mandates on the table when the CDC insists all of the health problems, hospitalizations, injuries and deaths that have been reported to the government's Vaccine Adverse Events Reporting System (VAERS) after Gardasil vaccination are just a "coincidence."
Through the end of October 2008, the government has published a list of 9,762 Gardasil- related adverse events, including 30 deaths, that have been reported to VAERS. This number does not include the Gardasil vaccine-related health problems which have been reported to the VAERS but not yet published. It is estimated that only between one and 10 percent of all serious health problems following administration of pharmaceutical products are ever reported to the government. This gross underreporting of vaccine- related hospitalizations, injuries and deaths means that there potentially could be nearly one million health problems following Gardasil vaccination that have actually occurred since the vaccine was licensed in 2006.
But who needs to count if it is all just a "coincidence?" It is good for business to downplay the significance of vaccine reactions and so researchers associated with Glaxo Smith Kline (GSK), who are perhaps looking toward the lucrative U.S. market for GSK's new HPV vaccine (Cervarix), are doing just that.
Waiting for approval at the FDA, Cervarix contains a powerful adjuvant (ASO4) that has not been licensed for use in the U.S. That adjuvant is designed to send the immune system into overdrive. Will it also swell the numbers of VAERS Gardasil adverse events reports that can be conveniently written off as a coincidence by doctors, government and drug company officials?
When perfectly healthy, bright teenage girls and young women get an HPV vaccination and collapse, have seizures, become paralyzed, are left with crippling fatigue and joint pain or suddenly die, their mothers and fathers deserve more than a "coincidence" explanation from doctors, government health officials and vaccine manufacturers. Until the public stands up to the Big Lie and calls it for what it is, those in charge of the U.S. vaccination system will continue to get away with putting policy and profits before good science every time a new vaccine is licensed and recommended for use by millions of Americans.
VIDEO: On Gardasil deaths click here
VIDEO: On Gardasil reactions click here
VIDEO: On Gardasil reactions click here
For Facts about HPV Infection click here
"Emily Tarsell has several paintings done by her daughter, Chris, hanging throughout her Baltimore County home. Chris Tarsell was a talented and aspiring artist, but she suddenly and inexplicably died in June at the age of 21. "No one heard from her," Tarsell said. "They went into her bedroom and found her in the bed, dead." Tarsell said she learned of her daughter's death when police officers knocked on her door. "It was about, I don't know, maybe eight o'clock. I was alone, and then they told me," she said. During an autopsy, a pathologist searched for the cause of Chris's death, but found none. Her final report listed cardiac arrest, cause undetermined, Miller reported. "They could not find anything. All the tests came back negative, so it's still unknown," Tarsell said. Weeks later, a family member mentioned to Tarsell news reports about Gardasil. "My sister and I were stunned," Tarsell said...."It's basically written off as a coincidence -- not connected," said Barbara Loe Fisher, a safety watchdog for the National Vaccine Information Center. She said she is critical of the CDC, FDA and Gardasil in particular, arguing the vaccine was put on the market too fast. "You cannot have the same people who are regulating, making policy for and promoting mass use of vaccines also in charge of making sure they're safe," Fisher said. She said a big shortcoming is the VAERS reporting system. "It's a very passive, voluntary system," she said." - Jayne Miller, WBAL-TV (Baltimore), November 21, 2008) www.youtube.com/watch?v=mqZNhOclixc
"Across the country different states including Arkansas have looked at mandating gardasil for school aged girls. It's a vaccine that helps prevent certain strains of HPV, the Human Papillomavirus which is a sexually transmitted disease that can lead to cervical cancer. But do the benefits outweigh the risks? Jesalee Parsons was 13 when her mother signed off on her to get the Gardasil vaccine at school. Now nearly two years later she says she is still in pain. Jesalee says she was diagnosed with Acute Pancreatitis and since getting one only dose of Gardasil has spent close to 100 days in the hospital, and had two surgeries to remove Pseudocysts. While doctors cannot explain why she has had health problems she and her mother are convinced the vaccine is to blame....Barbara Loe Fisher--President of the National Vaccine Information Center--wants parents to be informed before they allow their daughters to get the three dose vaccine. "We are seeing girls who are collapsing and then having seizure activity when they come to consciousness, continuing seizure disorders. We are seeing arthritis, chronic fatigue, paralysis. Some of these who are going in are perfectly healthy girls going in to get this vaccine and walk out and are chronically ill." The vaccine manufactured by Merck was tested on thousands of females in clinical trials prior to being approved but Fisher says it was not studied thoroughly enough in children. ""If your read the reports you can see certainly a number of them are related to that shot. These are healthy girls, healthy women who are going in and then dying, sometimes within hours, sometimes within days of getting this injection and often the autopsy reports come back with no known cause." - KATV-11 (Little Rock), November 6, 2008 http://www.katv.com/news/stories/110 8/567520_video.html?ref=newsstory
"A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday. The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.....Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.." - Reuters, December 2, 2008 http://www.reuters.com/article/healthNews/idUSTRE4B 20232008 1203
"Expected sluggish sales for some top products also is playing a role. Merck predicts sales of Gardasil to be flat in 2009 at $1.4 billion to $1.6 billion, a marked slowdown from the product's first couple of years. Merck said Gardasil already has achieved a high rate of vaccinations among girls 13 to 18 years old, and indicated it would be difficult to further boost the rate in this age group. The company also is trying to increase immunizations among women 19 to 26 years old, whose vaccination rate has been lower than expected. Merck has applied for U.S. regulatory approval to market Gardasil to women up to age 45 years old, and plans to file for approval by the end of December to market the vaccine to males ages 9 to 26, for the prevention of external lesions caused by the same virus that causes cervical cancer. It's also possible Gardasil will face new competition in the U.S. next year because GlaxoSmithKline (GSK) is awaiting regulatory decision on its own cervical- cancer vaccine, Cervarix." - Peter Loftus, Dow Jones Newswire (December 4, 2008) http://money.cnn.com/news/newsfeed s/articles/djf500/200812041031DOWJONESDJONLIN E000733_FORTUNE5.htm
At the same time that more Gardasil injuries and deaths are being reported every day, those promoting mass use of Gardasil are busy denying the significance of vaccine reactions while Merck is making plans to increase its market share by asking young boys to roll up their sleeves as well.
The discussion in states about whether or not Gardasil should be mandated is still taking place even though all but two state legislatures (Virginia and D.C.) rejected mandates in 2007. It makes it easier for pro- forced vaccination proponents to keep proposed Gardasil mandates on the table when the CDC insists all of the health problems, hospitalizations, injuries and deaths that have been reported to the government's Vaccine Adverse Events Reporting System (VAERS) after Gardasil vaccination are just a "coincidence."
Through the end of October 2008, the government has published a list of 9,762 Gardasil- related adverse events, including 30 deaths, that have been reported to VAERS. This number does not include the Gardasil vaccine-related health problems which have been reported to the VAERS but not yet published. It is estimated that only between one and 10 percent of all serious health problems following administration of pharmaceutical products are ever reported to the government. This gross underreporting of vaccine- related hospitalizations, injuries and deaths means that there potentially could be nearly one million health problems following Gardasil vaccination that have actually occurred since the vaccine was licensed in 2006.
But who needs to count if it is all just a "coincidence?" It is good for business to downplay the significance of vaccine reactions and so researchers associated with Glaxo Smith Kline (GSK), who are perhaps looking toward the lucrative U.S. market for GSK's new HPV vaccine (Cervarix), are doing just that.
Waiting for approval at the FDA, Cervarix contains a powerful adjuvant (ASO4) that has not been licensed for use in the U.S. That adjuvant is designed to send the immune system into overdrive. Will it also swell the numbers of VAERS Gardasil adverse events reports that can be conveniently written off as a coincidence by doctors, government and drug company officials?
When perfectly healthy, bright teenage girls and young women get an HPV vaccination and collapse, have seizures, become paralyzed, are left with crippling fatigue and joint pain or suddenly die, their mothers and fathers deserve more than a "coincidence" explanation from doctors, government health officials and vaccine manufacturers. Until the public stands up to the Big Lie and calls it for what it is, those in charge of the U.S. vaccination system will continue to get away with putting policy and profits before good science every time a new vaccine is licensed and recommended for use by millions of Americans.
VIDEO: On Gardasil deaths click here
VIDEO: On Gardasil reactions click here
VIDEO: On Gardasil reactions click here
For Facts about HPV Infection click here
"Emily Tarsell has several paintings done by her daughter, Chris, hanging throughout her Baltimore County home. Chris Tarsell was a talented and aspiring artist, but she suddenly and inexplicably died in June at the age of 21. "No one heard from her," Tarsell said. "They went into her bedroom and found her in the bed, dead." Tarsell said she learned of her daughter's death when police officers knocked on her door. "It was about, I don't know, maybe eight o'clock. I was alone, and then they told me," she said. During an autopsy, a pathologist searched for the cause of Chris's death, but found none. Her final report listed cardiac arrest, cause undetermined, Miller reported. "They could not find anything. All the tests came back negative, so it's still unknown," Tarsell said. Weeks later, a family member mentioned to Tarsell news reports about Gardasil. "My sister and I were stunned," Tarsell said...."It's basically written off as a coincidence -- not connected," said Barbara Loe Fisher, a safety watchdog for the National Vaccine Information Center. She said she is critical of the CDC, FDA and Gardasil in particular, arguing the vaccine was put on the market too fast. "You cannot have the same people who are regulating, making policy for and promoting mass use of vaccines also in charge of making sure they're safe," Fisher said. She said a big shortcoming is the VAERS reporting system. "It's a very passive, voluntary system," she said." - Jayne Miller, WBAL-TV (Baltimore), November 21, 2008) www.youtube.com/watch?v=mqZNhOclixc
"Across the country different states including Arkansas have looked at mandating gardasil for school aged girls. It's a vaccine that helps prevent certain strains of HPV, the Human Papillomavirus which is a sexually transmitted disease that can lead to cervical cancer. But do the benefits outweigh the risks? Jesalee Parsons was 13 when her mother signed off on her to get the Gardasil vaccine at school. Now nearly two years later she says she is still in pain. Jesalee says she was diagnosed with Acute Pancreatitis and since getting one only dose of Gardasil has spent close to 100 days in the hospital, and had two surgeries to remove Pseudocysts. While doctors cannot explain why she has had health problems she and her mother are convinced the vaccine is to blame....Barbara Loe Fisher--President of the National Vaccine Information Center--wants parents to be informed before they allow their daughters to get the three dose vaccine. "We are seeing girls who are collapsing and then having seizure activity when they come to consciousness, continuing seizure disorders. We are seeing arthritis, chronic fatigue, paralysis. Some of these who are going in are perfectly healthy girls going in to get this vaccine and walk out and are chronically ill." The vaccine manufactured by Merck was tested on thousands of females in clinical trials prior to being approved but Fisher says it was not studied thoroughly enough in children. ""If your read the reports you can see certainly a number of them are related to that shot. These are healthy girls, healthy women who are going in and then dying, sometimes within hours, sometimes within days of getting this injection and often the autopsy reports come back with no known cause." - KATV-11 (Little Rock), November 6, 2008 http://www.katv.com/news/stories/110 8/567520_video.html?ref=newsstory
"A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday. The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.....Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.." - Reuters, December 2, 2008 http://www.reuters.com/article/healthNews/idUSTRE4B 20232008 1203
"Expected sluggish sales for some top products also is playing a role. Merck predicts sales of Gardasil to be flat in 2009 at $1.4 billion to $1.6 billion, a marked slowdown from the product's first couple of years. Merck said Gardasil already has achieved a high rate of vaccinations among girls 13 to 18 years old, and indicated it would be difficult to further boost the rate in this age group. The company also is trying to increase immunizations among women 19 to 26 years old, whose vaccination rate has been lower than expected. Merck has applied for U.S. regulatory approval to market Gardasil to women up to age 45 years old, and plans to file for approval by the end of December to market the vaccine to males ages 9 to 26, for the prevention of external lesions caused by the same virus that causes cervical cancer. It's also possible Gardasil will face new competition in the U.S. next year because GlaxoSmithKline (GSK) is awaiting regulatory decision on its own cervical- cancer vaccine, Cervarix." - Peter Loftus, Dow Jones Newswire (December 4, 2008) http://money.cnn.com/news/newsfeed s/articles/djf500/200812041031DOWJONESDJONLIN E000733_FORTUNE5.htm
Vaccine Injury Compensation: A Failed Experiment in Tort Reform?
by Barbara Loe Fisher
On Nov. 14, 1986, President Ronald Reagan signed the National Childhood Vaccine Injury Act of 1986 into law, instituting first-time vaccine safety reforms in the U.S. vaccination system and creating the first no-fault federal vaccine injury compensation program alternative to a lawsuit against vaccine manufacturers and pediatricians. Twenty-two years later, on Nov. 18, 2008,
I made a statement to the Advisory Commission on Childhood Vaccines (ACCV) and questioned whether the compensation program is fatally flawed and so broken that it should be repealed. Many parents are wondering whether it would be better to return to civil court without restrictions to sue vaccine manufacturers and doctors for injuries and deaths their children suffered after receiving federally recommended vaccines.
During its two-decade history, two out of three individuals applying for federal vaccine injury compensation have been turned away empty-handed even though to date $1.8B has been awarded to more than 2,200 plaintiff's out of some 12,000 who have applied. Today, nearly 5,000 vaccine injury claims are sitting in limbo because they represent children, who suffered brain and immune system dysfunction after vaccination but have been diagnosed with regressive autism, which is not recognized by the program as a compensable event. There is $2.7B sitting in the Trust Fund which could have been awarded to vaccine victims.
At the time of the law's creation in 1986, Congress said they were committed to setting up a fair, expedited, non-adversarial, less traumatic, less expensive no-fault compensation mechanism alternative to civil litigation. But Congress also acknowledged that any legislation providing liability protection must also be equally committed to preventing vaccine harm. The Act contains strong safety provisions, including first-time mandates for doctors to record and report serious health problems, hospitalizations, injuries and deaths after vaccination and give parents written benefit and risk information before a child is vaccinated.
But few of the safety provisions have been enforced and, as I testified in Congress in 1999 and again at the Nov. 18 ACCV meeting, there has been a betrayal of the promise that was made to parents about how the compensation program would be implemented. Obtaining compensation has become a highly adversarial, time-consuming, traumatic and expensive process for families of vaccine injured children and far too many vaccine victims have been denied compensation while vaccine makers and doctors have enjoyed liability protection and dozens of doses of nine new vaccines have been added to the childhood vaccine schedule.
I pointed out that federal court judges are beginning to look back at the legislative history of the Act, which so clearly affirms the intent of Congress when creating it. In recent court decisions, judges have agreed with parents and their attorneys that the compensation program has become far too difficult for plaintiffs. A recent state Supreme Court ruling also reiterated that Congress never intended to shield vaccine manufacturers from ALL liability for vaccine injuries and deaths when it could be demonstrated that a safer product could have been marketed.
In a Supreme Court of Georgia ruling on October 6, 2008 in American Home Products v. Ferrari, the justices unanimously held that the National Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it can be proven that the company could have made a safer vaccine. Georgia Supreme Court Justice George Carley wrote that the 1986 law and "the congressional intent behind it shows that the Vaccine Act does not pre-empt all design defect claims." He added that Congress did not "use language which indicates that use of the compensation system is mandatory" but only "an appealing alternative" to the courts.
Justice Carley wrote that there is no evidence that "FDA approval alone renders a vaccine unavoidably safe" and said "We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval," adding that to do so would have "the perverse effect" of granting complete immunity from liability to an entire industry and he concluded that "in the absence of any clear and manifest congressional purpose to achieve that result, we must reject such a far-reaching interpretation."
During the ACCV meeting, longtime plaintiff's attorney Sherry Drew gave a moving description of the suffering that families with vaccine injured children endure and, during public comment at the end of the meeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined me in urging the Committee to recommend to the new Secretary of DHHS that more vaccine injured children be compensated. This was echoed by outgoing parent ACCV member Tawny Buck, of Alaska, who has a DPT vaccine injured daughter and new ACCV parent member Sarah Hoiberg, of Florida, who has a five-year old DTaP vaccine injured daughter.
In the 1986 Vaccine Injury Act, the Institute of Medicine was directed to review the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in landmark reports to Congress in 1991 and 1994 providing that evidence. IOM announced at the ACCV meeting that it has recently been contracted by the Health Resources & Services Administration (HRSA) to assemble a Committee of scientific experts to review of the medical literature for evidence regarding the biological mechanisms for injury and death in association with varicella zoster (chicken pox), hepatitis B, meningococcal and HPV vaccine. There will be several public workshops during the Committee's two- year study.
NVIC has been calling for basic science research into the biological mechanisms of vaccine injury and death for more than two decades. Without understanding how and why vaccines can cause brain and immune system dysfunction, there will be no way to develop pathological profiles to help scientifically confirm whether or not an individual has been injured or died from vaccination.
The truth about vaccine risks lies in the science, properly designed and conducted. The upcoming IOM review may be hampered by a lack of biological mechanism studies published in the medical literature but the review is also an opportunity to point the way to fill in those gaps in knowledge and the need for additional research that could become part of a national vaccine safety research agenda.
In the absence of scientific certainty, all children who regress into poor health after vaccination should be given a fair hearing in the federal vaccine injury compensation program and generously compensated when no other plausible cause can be found for what happened to them after vaccination. Congress intended the vaccine injury compensation program to be non-adversarial, fair, generous and humane. If it cannot function the way it was intended to function, then parents have every right to call for its repeal and a return to unrestricted lawsuits.
Click here to read my entire ACCV statement with live links to the 1986 Vaccine Injury Act, U.S. Court of Appeals decisions, congressional testimony and other original sources.
Click here for ACCV meeting minutes and dates for upcoming meetings, which can be accessed via tele-conference call by the public who cannot attend the Rockville, Maryland meetings in person.
On Nov. 14, 1986, President Ronald Reagan signed the National Childhood Vaccine Injury Act of 1986 into law, instituting first-time vaccine safety reforms in the U.S. vaccination system and creating the first no-fault federal vaccine injury compensation program alternative to a lawsuit against vaccine manufacturers and pediatricians. Twenty-two years later, on Nov. 18, 2008,
I made a statement to the Advisory Commission on Childhood Vaccines (ACCV) and questioned whether the compensation program is fatally flawed and so broken that it should be repealed. Many parents are wondering whether it would be better to return to civil court without restrictions to sue vaccine manufacturers and doctors for injuries and deaths their children suffered after receiving federally recommended vaccines.
During its two-decade history, two out of three individuals applying for federal vaccine injury compensation have been turned away empty-handed even though to date $1.8B has been awarded to more than 2,200 plaintiff's out of some 12,000 who have applied. Today, nearly 5,000 vaccine injury claims are sitting in limbo because they represent children, who suffered brain and immune system dysfunction after vaccination but have been diagnosed with regressive autism, which is not recognized by the program as a compensable event. There is $2.7B sitting in the Trust Fund which could have been awarded to vaccine victims.
At the time of the law's creation in 1986, Congress said they were committed to setting up a fair, expedited, non-adversarial, less traumatic, less expensive no-fault compensation mechanism alternative to civil litigation. But Congress also acknowledged that any legislation providing liability protection must also be equally committed to preventing vaccine harm. The Act contains strong safety provisions, including first-time mandates for doctors to record and report serious health problems, hospitalizations, injuries and deaths after vaccination and give parents written benefit and risk information before a child is vaccinated.
But few of the safety provisions have been enforced and, as I testified in Congress in 1999 and again at the Nov. 18 ACCV meeting, there has been a betrayal of the promise that was made to parents about how the compensation program would be implemented. Obtaining compensation has become a highly adversarial, time-consuming, traumatic and expensive process for families of vaccine injured children and far too many vaccine victims have been denied compensation while vaccine makers and doctors have enjoyed liability protection and dozens of doses of nine new vaccines have been added to the childhood vaccine schedule.
I pointed out that federal court judges are beginning to look back at the legislative history of the Act, which so clearly affirms the intent of Congress when creating it. In recent court decisions, judges have agreed with parents and their attorneys that the compensation program has become far too difficult for plaintiffs. A recent state Supreme Court ruling also reiterated that Congress never intended to shield vaccine manufacturers from ALL liability for vaccine injuries and deaths when it could be demonstrated that a safer product could have been marketed.
In a Supreme Court of Georgia ruling on October 6, 2008 in American Home Products v. Ferrari, the justices unanimously held that the National Childhood Vaccine Injury Act does not give a vaccine manufacturer blanket immunity from vaccine injury lawsuits if it can be proven that the company could have made a safer vaccine. Georgia Supreme Court Justice George Carley wrote that the 1986 law and "the congressional intent behind it shows that the Vaccine Act does not pre-empt all design defect claims." He added that Congress did not "use language which indicates that use of the compensation system is mandatory" but only "an appealing alternative" to the courts.
Justice Carley wrote that there is no evidence that "FDA approval alone renders a vaccine unavoidably safe" and said "We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval," adding that to do so would have "the perverse effect" of granting complete immunity from liability to an entire industry and he concluded that "in the absence of any clear and manifest congressional purpose to achieve that result, we must reject such a far-reaching interpretation."
During the ACCV meeting, longtime plaintiff's attorney Sherry Drew gave a moving description of the suffering that families with vaccine injured children endure and, during public comment at the end of the meeting, Jim Moody, of SafeMinds, and Vicky Debold, RN, PhD joined me in urging the Committee to recommend to the new Secretary of DHHS that more vaccine injured children be compensated. This was echoed by outgoing parent ACCV member Tawny Buck, of Alaska, who has a DPT vaccine injured daughter and new ACCV parent member Sarah Hoiberg, of Florida, who has a five-year old DTaP vaccine injured daughter.
In the 1986 Vaccine Injury Act, the Institute of Medicine was directed to review the medical literature for scientific evidence that vaccines can cause injury and death, which resulted in landmark reports to Congress in 1991 and 1994 providing that evidence. IOM announced at the ACCV meeting that it has recently been contracted by the Health Resources & Services Administration (HRSA) to assemble a Committee of scientific experts to review of the medical literature for evidence regarding the biological mechanisms for injury and death in association with varicella zoster (chicken pox), hepatitis B, meningococcal and HPV vaccine. There will be several public workshops during the Committee's two- year study.
NVIC has been calling for basic science research into the biological mechanisms of vaccine injury and death for more than two decades. Without understanding how and why vaccines can cause brain and immune system dysfunction, there will be no way to develop pathological profiles to help scientifically confirm whether or not an individual has been injured or died from vaccination.
The truth about vaccine risks lies in the science, properly designed and conducted. The upcoming IOM review may be hampered by a lack of biological mechanism studies published in the medical literature but the review is also an opportunity to point the way to fill in those gaps in knowledge and the need for additional research that could become part of a national vaccine safety research agenda.
In the absence of scientific certainty, all children who regress into poor health after vaccination should be given a fair hearing in the federal vaccine injury compensation program and generously compensated when no other plausible cause can be found for what happened to them after vaccination. Congress intended the vaccine injury compensation program to be non-adversarial, fair, generous and humane. If it cannot function the way it was intended to function, then parents have every right to call for its repeal and a return to unrestricted lawsuits.
Click here to read my entire ACCV statement with live links to the 1986 Vaccine Injury Act, U.S. Court of Appeals decisions, congressional testimony and other original sources.
Click here for ACCV meeting minutes and dates for upcoming meetings, which can be accessed via tele-conference call by the public who cannot attend the Rockville, Maryland meetings in person.
Flu & You: Know Your Options
by Barbara Loe Fisher
These days you can't turn around without being reminded that the "flu" season is just around the corner and it is time for every American - but especially infants, kindergarteners through high school graduates and anyone over 50 - to get a shot of influenza vaccine. But there are lots of new questions about whether the influenza vaccine is ineffective in children and whether it is also ineffective in the elderly at the same time there are growing doubts about whether many doctors and health officials have told the public the truth and nothing but the truth about the risks associated with infectious disease and the risks associated with vaccination.
Christian Broadcasting Network (CBN) has produced several investigative reports on vaccination during the past several years and a recent CBN report on influenza vaccine examined the validity of the annual influenza mortality figure that the CDC routinely uses (36,000 deaths per year in the U.S. from influenza). The report also presented several perspectives about getting a flu shot versus using a more natural approach to staying well in the flu season. (See VIDEO of report as well as VIDEO outtakes not included in the broadast story featuring Vitamin D Council Executive Director John Cannell, M.D. on pandemic influenza, Heather Maurer on how she made an educated flu shot decision for her child; Virginia Health Commissioner Karen Remley, M.D. on why public health officials like flu shots; and my comments on "cradle-to-grave" vaccine policies and development of a "supervaccine.")
Joseph Mercola, M.D., a champion of the holistic health and wellness lifestyle and strong advocate for the informed consent ethic in medicine, frequently offers alternative perspectives about infectious disease and vaccination. See Dr. Mercola's past newsletters discussing flu vaccination and other vaccination topics at www.mercola.com and view a speech I gave at the Natural Living Conference sponsored by Holistic Moms Network on his website.
In the coming months, the push for Americans to get flu shots will increase but how many will understand the government-acknowledged risks and precautions for inactivated, injected influenza vaccine or the live virus nasal influenza vaccine which are more fully outlined in the manufacturer's product inserts available on the web and at pharmacies and in doctor's offices?
How many Americans know there are practical steps to take during the flu season that will not only help protect against all infections, including actual influenza as well as other "flu-like illnesses" that can often be mistaken for influenza? (Only about 20 percent of all "flu-like" illness is actually influenza and only three strains of the many strains of type A and type B influenza that may be circulating during the year are actually included in the influenza vaccine).
To prevent and treat influenza or flu-like respiratory illness that does not involve fever over 103 F., pneumonia or serious complications which may require medical intervention, the National Vaccine Information Center offers the following non- toxic suggestions:
1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamin D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.
Whatever you do this flu season - whether or not you choose to vaccinate - become vaccine educated and know your options.
Knowledge is power and an informed, empowered consumer is one who can stand up for the right to freely exercise informed preventive health options.
See www.NVIC.org and www.StandUpBeCounted.org for more information. Please email PaulNVIC@gmail.com if you would like to volunteer to work in your state to help NVIC educate Americans about vaccination or have special expertise you would like to share. NVIC is also looking for volunteers in the Northern Virginia and greater Washington, D.C. area to assist our staff with many exciting and challenging projects.
"The federal government finds of that 36,000, about 1,000 people die directly from the flu virus. Blame for the remaining 35,000 deaths goes to diseases like pneumonia that may follow the flu. However there's no clear scientific connection between the flu and these more serious afflictions. That means most of the time the shot would have little impact in actually preventing death. Barbara Loe Fisher heads of the non-governmental National Vaccine Information Center. She says the repeated references to 36,000 seems to be an attempt to scare people into getting the shot. Fisher suggests the public is smart enough to decide independently. A free market would be better, she believes. "If we allow vaccines to be subject to the test of the marketplace, then the public will use those vaccines they consider to be safe, effective, and necessary," Fisher says......Dr. John Cannell, Executive Director of the Vitamin D Council, suggests the reason we even have a flu season is because our vitamin D levels drop. That takes place naturally as we get less and less sun with the approach of winter. Cannell explains that less sun means we produce less vitamin D in our skin. "Pretty much any disease, any infectious disease, that is more common in winter is a target of vitamin D," Cannell says. He says that's true even of some serious non-seasonal, prolonged diseases such as tuberculosis. Early in the 19th century, TB sanitariums where people would get sun were one of the few ways to recover from "consumption," as it was known. So Cannell suggests babies get a 1,000 units a day and those two and older get 2,000 units. Many adults and some children need to take more than that. For kids, that can come as a single daily drop of liquid D. Cannell says a recent discovery explains vitamin D's role in the flu season. The vitamin triggers your body to produce its own antibiotics against flu as well as colds." - Gailon Totheroh, CBN News Service (November 4, 2008) VIDEOS at http://www.cbn.com/CBNnews/475564.aspx and http: //www.cbn.com/cbnnews/479085.aspx
"Led by Dr. Peter Szilagyi, researchers at University of Rochester studied 414 children aged 5 and younger, who came down with the flu during the 2003-2004 or 2004-2005 flu seasons. These children were compared with over 5,000 controls who did not have influenza during the same seasons. Turns out that flu shots seemed not to make much difference: Kids who got immunized did not get the flu at lower rates than unvaccinated kids. In fact, the immunized youngsters were just as likely to be hospitalized or to visit the doctor as kids who never received the vaccine.......Targeting the correct strain is a always a bit of a guessing game, however; researchers make their best scientifically based prediction as to which flu virus will be making the rounds in a coming season, but they often have to make these predictions up to nine months ahead of time, in order to keep up with the lengthy vaccine manufacturing process. "In some circumstances, it is like forecasting the weather," says Dr. Geoffrey Weinberg, professor of pediatrics at University of Rochester. "Sometimes we are right on, and sometimes we are off." - Alice Park, Time Magazine (October 6 2008) http://www.time.com/time/health/artic le/0,8599,1847794,00.html
"The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly. A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths. The latest blow was a study in The Lancet last month that called into question much of the statistical evidence for the vaccine's effectiveness. The authors said previous studies had measured the wrong thing: not any actual protection against the flu virus but a fundamental difference between the kinds of people who get vaccines and those who do not. This contention is far from universally accepted. And even skeptics say that until more effective measures are found, older people should continue to be vaccinated, because some protection against the flu is better than none. Still, the Lancet article has reignited a longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people. "The whole notion of who needs the vaccine and why is changing before our eyes," said Peter Doshi, a doctoral candidate at M.I.T. who published a paper on the historical impact of influenza in May in The American Journal of Public Health ." - Brenda Goodman, New York Times (September 2, 2008) http://www.nytimes.com/2008/09/02/health/02flu. html
These days you can't turn around without being reminded that the "flu" season is just around the corner and it is time for every American - but especially infants, kindergarteners through high school graduates and anyone over 50 - to get a shot of influenza vaccine. But there are lots of new questions about whether the influenza vaccine is ineffective in children and whether it is also ineffective in the elderly at the same time there are growing doubts about whether many doctors and health officials have told the public the truth and nothing but the truth about the risks associated with infectious disease and the risks associated with vaccination.
Christian Broadcasting Network (CBN) has produced several investigative reports on vaccination during the past several years and a recent CBN report on influenza vaccine examined the validity of the annual influenza mortality figure that the CDC routinely uses (36,000 deaths per year in the U.S. from influenza). The report also presented several perspectives about getting a flu shot versus using a more natural approach to staying well in the flu season. (See VIDEO of report as well as VIDEO outtakes not included in the broadast story featuring Vitamin D Council Executive Director John Cannell, M.D. on pandemic influenza, Heather Maurer on how she made an educated flu shot decision for her child; Virginia Health Commissioner Karen Remley, M.D. on why public health officials like flu shots; and my comments on "cradle-to-grave" vaccine policies and development of a "supervaccine.")
Joseph Mercola, M.D., a champion of the holistic health and wellness lifestyle and strong advocate for the informed consent ethic in medicine, frequently offers alternative perspectives about infectious disease and vaccination. See Dr. Mercola's past newsletters discussing flu vaccination and other vaccination topics at www.mercola.com and view a speech I gave at the Natural Living Conference sponsored by Holistic Moms Network on his website.
In the coming months, the push for Americans to get flu shots will increase but how many will understand the government-acknowledged risks and precautions for inactivated, injected influenza vaccine or the live virus nasal influenza vaccine which are more fully outlined in the manufacturer's product inserts available on the web and at pharmacies and in doctor's offices?
How many Americans know there are practical steps to take during the flu season that will not only help protect against all infections, including actual influenza as well as other "flu-like illnesses" that can often be mistaken for influenza? (Only about 20 percent of all "flu-like" illness is actually influenza and only three strains of the many strains of type A and type B influenza that may be circulating during the year are actually included in the influenza vaccine).
To prevent and treat influenza or flu-like respiratory illness that does not involve fever over 103 F., pneumonia or serious complications which may require medical intervention, the National Vaccine Information Center offers the following non- toxic suggestions:
1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamin D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.
Whatever you do this flu season - whether or not you choose to vaccinate - become vaccine educated and know your options.
Knowledge is power and an informed, empowered consumer is one who can stand up for the right to freely exercise informed preventive health options.
See www.NVIC.org and www.StandUpBeCounted.org for more information. Please email PaulNVIC@gmail.com if you would like to volunteer to work in your state to help NVIC educate Americans about vaccination or have special expertise you would like to share. NVIC is also looking for volunteers in the Northern Virginia and greater Washington, D.C. area to assist our staff with many exciting and challenging projects.
"The federal government finds of that 36,000, about 1,000 people die directly from the flu virus. Blame for the remaining 35,000 deaths goes to diseases like pneumonia that may follow the flu. However there's no clear scientific connection between the flu and these more serious afflictions. That means most of the time the shot would have little impact in actually preventing death. Barbara Loe Fisher heads of the non-governmental National Vaccine Information Center. She says the repeated references to 36,000 seems to be an attempt to scare people into getting the shot. Fisher suggests the public is smart enough to decide independently. A free market would be better, she believes. "If we allow vaccines to be subject to the test of the marketplace, then the public will use those vaccines they consider to be safe, effective, and necessary," Fisher says......Dr. John Cannell, Executive Director of the Vitamin D Council, suggests the reason we even have a flu season is because our vitamin D levels drop. That takes place naturally as we get less and less sun with the approach of winter. Cannell explains that less sun means we produce less vitamin D in our skin. "Pretty much any disease, any infectious disease, that is more common in winter is a target of vitamin D," Cannell says. He says that's true even of some serious non-seasonal, prolonged diseases such as tuberculosis. Early in the 19th century, TB sanitariums where people would get sun were one of the few ways to recover from "consumption," as it was known. So Cannell suggests babies get a 1,000 units a day and those two and older get 2,000 units. Many adults and some children need to take more than that. For kids, that can come as a single daily drop of liquid D. Cannell says a recent discovery explains vitamin D's role in the flu season. The vitamin triggers your body to produce its own antibiotics against flu as well as colds." - Gailon Totheroh, CBN News Service (November 4, 2008) VIDEOS at http://www.cbn.com/CBNnews/475564.aspx and http: //www.cbn.com/cbnnews/479085.aspx
"Led by Dr. Peter Szilagyi, researchers at University of Rochester studied 414 children aged 5 and younger, who came down with the flu during the 2003-2004 or 2004-2005 flu seasons. These children were compared with over 5,000 controls who did not have influenza during the same seasons. Turns out that flu shots seemed not to make much difference: Kids who got immunized did not get the flu at lower rates than unvaccinated kids. In fact, the immunized youngsters were just as likely to be hospitalized or to visit the doctor as kids who never received the vaccine.......Targeting the correct strain is a always a bit of a guessing game, however; researchers make their best scientifically based prediction as to which flu virus will be making the rounds in a coming season, but they often have to make these predictions up to nine months ahead of time, in order to keep up with the lengthy vaccine manufacturing process. "In some circumstances, it is like forecasting the weather," says Dr. Geoffrey Weinberg, professor of pediatrics at University of Rochester. "Sometimes we are right on, and sometimes we are off." - Alice Park, Time Magazine (October 6 2008) http://www.time.com/time/health/artic le/0,8599,1847794,00.html
"The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly. A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths. The latest blow was a study in The Lancet last month that called into question much of the statistical evidence for the vaccine's effectiveness. The authors said previous studies had measured the wrong thing: not any actual protection against the flu virus but a fundamental difference between the kinds of people who get vaccines and those who do not. This contention is far from universally accepted. And even skeptics say that until more effective measures are found, older people should continue to be vaccinated, because some protection against the flu is better than none. Still, the Lancet article has reignited a longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people. "The whole notion of who needs the vaccine and why is changing before our eyes," said Peter Doshi, a doctoral candidate at M.I.T. who published a paper on the historical impact of influenza in May in The American Journal of Public Health ." - Brenda Goodman, New York Times (September 2, 2008) http://www.nytimes.com/2008/09/02/health/02flu. html
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